Chemistry Manufacturing and Controls- Regulatory Challenges and Solution

2

Featured Speaker

Dr Mandakini Goel

Sr Solution Consultant South Asia

Clarivate Analytics

3

Agenda

4

6

7

8

15

1 Health for Allhellip

2 Regulatory Approval Processes- Challenges and Implications

3 Why CMC

4 Common Challenges for CMC professionals-Deep Dive

5 Use Cases

4

Sustainable Development Goal 38 of the United Nations-promotion of health through expanded access to quality assured medicines

Health for Allhellip

Manufacturing controls amp Quality assurance systems are the foundation for assuring quality products

Challenge is the easy access of up-to-date manufacturing control requirements- LMIC countries

- Lower and middle income countries

5

Global burden of diseases-

bull Malaria ndash 90 of the cases were in the WHO African Region followed by the WHO South-East Asia Region (7) and the WHO Eastern Mediterranean Region (2) Of the 91 countries reporting indigenous malaria cases in 2016 15 countries ndash all in sub-Saharan Africa except India ndash carried 80 of the global malaria burden

bull Tuberculosis- 86 million new cases

bull HIV- 80 of people living with HIV

Regulatory Challenges-

bull Navigation of regulatory requirements

bull Location and Interpretation of CMC requirements

bull Variations in regional requirements

bull Varying levels of regulatory enforcement maturity

bull Lack of awareness

Why LMICs

6

Many manufacturersrsquo use regulatory programmes such as WHO Prequalification Programme (PQ) and USFDArsquos PEPFAR tentative approval pathway However individual countryrsquos approval through National Regulatory Authority might be required to launch the drugs in country of interest to ensure that the products entering these markets are safe efficacious and meet the requisite manufacturing quality standards and comply to importexport requirements

Challenges faced by manufacturers in product development partnerships which might lead to delay in product launch

bull Stability Studies

bull GMP Inspections

bull Labelling

bull Packaging

bull In country QC testing

bull National Regulatory Authority Approval

bull Reference product selection

Regulatory Approval Processes- Challenges and Implications

The lack of visibility of regulatory requirements can result in higher costs and patientsrsquo delayed access to drugs

$15 million

7

The importance of CMC activities - By the numbers

8

bull Lack of CMC understanding for markets of interest can

bull Discourage companies from pursuing new markets

bull Lead to investing significant time and money in pursuing projects that are not a good fit

bull Lock companies into suboptimal partnerships

bull Increase the cost of market entry

bull Without proper understanding of CMC requirements companies risk spending significant amounts of money on unnecessary (or incorrect) testing and transportation options

bull Delay market entry

bull Potentially lead to product rejections on the border after approval

In the Generics Industry Speed and Efficiency Are Paramount

There is a definitive need to make sure that you have access to the highest quality and most up to date CMC information to avoid submission delays and successfully bring a drug to market to avoid extended timelines unplanned costs and loss of forecasted revenue

9

Common Challenges for CMC Professionals

bull Efficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations

bull Select countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Choose the optimal path to market by pinpointing potential approval pathways

bull Develop CMC strategies to balance cost time and quality risk

bull Fully understand requirements around testing and manufacturing before making decisions around who to partner with

Cortellis CMC Intelligence

Donrsquot let lack of regulatory intelligence get in the way of your success

10

ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations

bull Access country-specific reports comprising of

bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC

requirementsbull Procedure Visualizationsbull Registration Pathways

11

Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices

bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs

12

Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways

bull Access detailed workflows for regulatory submission procedures

bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification

13

Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk

bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business

bull Understand detailed requirements to better develop your CMC strategy

14

Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with

bull Understand official regulations and local practices of potential partner company locations

bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy

Use Cases

16

❶

❷

❸

❶

bull Select multiple countries of interestbull Drill down appropriate requirements view

Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form

❹

❹

❸

View Reportsbull View country-specific reports comprising

bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources

❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries

Cortellis CMC Intelligence Workflow

17

Use Case 01 ndash Registering a new product in a single country

A pharmaceutical client is registering a new product in Brazil and is

contracting the final release and packaging to a local manufacturer

What documents does the local packager need to provide to us for our submission

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

View Report ndash Detailed Requirements

Brazil selected

View Report active

18Use Case 02 ndash Registering a new product in multiple countries

A pharmaceutical client is registering a new product in Brazil Colombia

and Peru and is contracting the final release and packaging to a local

manufacturer

What documents does the local packager need to provide to us for our

submission

What differences in requirements are there across the targeted countries

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

Compare Detailed Requirements

Multiple countriesselected

View Compare Detailed Requirements active

19Use Case 03 ndash Flagging high level differences in requirements across in

multiple countries

A pharmaceutical client is registering a new product in Brazil

Colombia and Peru and is contracting the final release and

packaging to a local manufacturer

What high level differences in requirements are there across the targeted countries

Compare Summary Requirements

Multiple countriesselected

View Compare Summary Requirements active

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

2

Featured Speaker

Dr Mandakini Goel

Sr Solution Consultant South Asia

Clarivate Analytics

3

Agenda

4

6

7

8

15

1 Health for Allhellip

2 Regulatory Approval Processes- Challenges and Implications

3 Why CMC

4 Common Challenges for CMC professionals-Deep Dive

5 Use Cases

4

Sustainable Development Goal 38 of the United Nations-promotion of health through expanded access to quality assured medicines

Health for Allhellip

Manufacturing controls amp Quality assurance systems are the foundation for assuring quality products

Challenge is the easy access of up-to-date manufacturing control requirements- LMIC countries

- Lower and middle income countries

5

Global burden of diseases-

bull Malaria ndash 90 of the cases were in the WHO African Region followed by the WHO South-East Asia Region (7) and the WHO Eastern Mediterranean Region (2) Of the 91 countries reporting indigenous malaria cases in 2016 15 countries ndash all in sub-Saharan Africa except India ndash carried 80 of the global malaria burden

bull Tuberculosis- 86 million new cases

bull HIV- 80 of people living with HIV

Regulatory Challenges-

bull Navigation of regulatory requirements

bull Location and Interpretation of CMC requirements

bull Variations in regional requirements

bull Varying levels of regulatory enforcement maturity

bull Lack of awareness

Why LMICs

6

Many manufacturersrsquo use regulatory programmes such as WHO Prequalification Programme (PQ) and USFDArsquos PEPFAR tentative approval pathway However individual countryrsquos approval through National Regulatory Authority might be required to launch the drugs in country of interest to ensure that the products entering these markets are safe efficacious and meet the requisite manufacturing quality standards and comply to importexport requirements

Challenges faced by manufacturers in product development partnerships which might lead to delay in product launch

bull Stability Studies

bull GMP Inspections

bull Labelling

bull Packaging

bull In country QC testing

bull National Regulatory Authority Approval

bull Reference product selection

Regulatory Approval Processes- Challenges and Implications

The lack of visibility of regulatory requirements can result in higher costs and patientsrsquo delayed access to drugs

$15 million

7

The importance of CMC activities - By the numbers

8

bull Lack of CMC understanding for markets of interest can

bull Discourage companies from pursuing new markets

bull Lead to investing significant time and money in pursuing projects that are not a good fit

bull Lock companies into suboptimal partnerships

bull Increase the cost of market entry

bull Without proper understanding of CMC requirements companies risk spending significant amounts of money on unnecessary (or incorrect) testing and transportation options

bull Delay market entry

bull Potentially lead to product rejections on the border after approval

In the Generics Industry Speed and Efficiency Are Paramount

There is a definitive need to make sure that you have access to the highest quality and most up to date CMC information to avoid submission delays and successfully bring a drug to market to avoid extended timelines unplanned costs and loss of forecasted revenue

9

Common Challenges for CMC Professionals

bull Efficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations

bull Select countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Choose the optimal path to market by pinpointing potential approval pathways

bull Develop CMC strategies to balance cost time and quality risk

bull Fully understand requirements around testing and manufacturing before making decisions around who to partner with

Cortellis CMC Intelligence

Donrsquot let lack of regulatory intelligence get in the way of your success

10

ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations

bull Access country-specific reports comprising of

bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC

requirementsbull Procedure Visualizationsbull Registration Pathways

11

Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices

bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs

12

Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways

bull Access detailed workflows for regulatory submission procedures

bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification

13

Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk

bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business

bull Understand detailed requirements to better develop your CMC strategy

14

Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with

bull Understand official regulations and local practices of potential partner company locations

bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy

Use Cases

16

❶

❷

❸

❶

bull Select multiple countries of interestbull Drill down appropriate requirements view

Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form

❹

❹

❸

View Reportsbull View country-specific reports comprising

bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources

❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries

Cortellis CMC Intelligence Workflow

17

Use Case 01 ndash Registering a new product in a single country

A pharmaceutical client is registering a new product in Brazil and is

contracting the final release and packaging to a local manufacturer

What documents does the local packager need to provide to us for our submission

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

View Report ndash Detailed Requirements

Brazil selected

View Report active

18Use Case 02 ndash Registering a new product in multiple countries

A pharmaceutical client is registering a new product in Brazil Colombia

and Peru and is contracting the final release and packaging to a local

manufacturer

What documents does the local packager need to provide to us for our

submission

What differences in requirements are there across the targeted countries

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

Compare Detailed Requirements

Multiple countriesselected

View Compare Detailed Requirements active

19Use Case 03 ndash Flagging high level differences in requirements across in

multiple countries

A pharmaceutical client is registering a new product in Brazil

Colombia and Peru and is contracting the final release and

packaging to a local manufacturer

What high level differences in requirements are there across the targeted countries

Compare Summary Requirements

Multiple countriesselected

View Compare Summary Requirements active

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

3

Agenda

4

6

7

8

15

1 Health for Allhellip

2 Regulatory Approval Processes- Challenges and Implications

3 Why CMC

4 Common Challenges for CMC professionals-Deep Dive

5 Use Cases

4

Sustainable Development Goal 38 of the United Nations-promotion of health through expanded access to quality assured medicines

Health for Allhellip

Manufacturing controls amp Quality assurance systems are the foundation for assuring quality products

Challenge is the easy access of up-to-date manufacturing control requirements- LMIC countries

- Lower and middle income countries

5

Global burden of diseases-

bull Malaria ndash 90 of the cases were in the WHO African Region followed by the WHO South-East Asia Region (7) and the WHO Eastern Mediterranean Region (2) Of the 91 countries reporting indigenous malaria cases in 2016 15 countries ndash all in sub-Saharan Africa except India ndash carried 80 of the global malaria burden

bull Tuberculosis- 86 million new cases

bull HIV- 80 of people living with HIV

Regulatory Challenges-

bull Navigation of regulatory requirements

bull Location and Interpretation of CMC requirements

bull Variations in regional requirements

bull Varying levels of regulatory enforcement maturity

bull Lack of awareness

Why LMICs

6

Many manufacturersrsquo use regulatory programmes such as WHO Prequalification Programme (PQ) and USFDArsquos PEPFAR tentative approval pathway However individual countryrsquos approval through National Regulatory Authority might be required to launch the drugs in country of interest to ensure that the products entering these markets are safe efficacious and meet the requisite manufacturing quality standards and comply to importexport requirements

Challenges faced by manufacturers in product development partnerships which might lead to delay in product launch

bull Stability Studies

bull GMP Inspections

bull Labelling

bull Packaging

bull In country QC testing

bull National Regulatory Authority Approval

bull Reference product selection

Regulatory Approval Processes- Challenges and Implications

The lack of visibility of regulatory requirements can result in higher costs and patientsrsquo delayed access to drugs

$15 million

7

The importance of CMC activities - By the numbers

8

bull Lack of CMC understanding for markets of interest can

bull Discourage companies from pursuing new markets

bull Lead to investing significant time and money in pursuing projects that are not a good fit

bull Lock companies into suboptimal partnerships

bull Increase the cost of market entry

bull Without proper understanding of CMC requirements companies risk spending significant amounts of money on unnecessary (or incorrect) testing and transportation options

bull Delay market entry

bull Potentially lead to product rejections on the border after approval

In the Generics Industry Speed and Efficiency Are Paramount

There is a definitive need to make sure that you have access to the highest quality and most up to date CMC information to avoid submission delays and successfully bring a drug to market to avoid extended timelines unplanned costs and loss of forecasted revenue

9

Common Challenges for CMC Professionals

bull Efficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations

bull Select countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Choose the optimal path to market by pinpointing potential approval pathways

bull Develop CMC strategies to balance cost time and quality risk

bull Fully understand requirements around testing and manufacturing before making decisions around who to partner with

Cortellis CMC Intelligence

Donrsquot let lack of regulatory intelligence get in the way of your success

10

ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations

bull Access country-specific reports comprising of

bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC

requirementsbull Procedure Visualizationsbull Registration Pathways

11

Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices

bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs

12

Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways

bull Access detailed workflows for regulatory submission procedures

bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification

13

Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk

bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business

bull Understand detailed requirements to better develop your CMC strategy

14

Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with

bull Understand official regulations and local practices of potential partner company locations

bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy

Use Cases

16

❶

❷

❸

❶

bull Select multiple countries of interestbull Drill down appropriate requirements view

Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form

❹

❹

❸

View Reportsbull View country-specific reports comprising

bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources

❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries

Cortellis CMC Intelligence Workflow

17

Use Case 01 ndash Registering a new product in a single country

A pharmaceutical client is registering a new product in Brazil and is

contracting the final release and packaging to a local manufacturer

What documents does the local packager need to provide to us for our submission

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

View Report ndash Detailed Requirements

Brazil selected

View Report active

18Use Case 02 ndash Registering a new product in multiple countries

A pharmaceutical client is registering a new product in Brazil Colombia

and Peru and is contracting the final release and packaging to a local

manufacturer

What documents does the local packager need to provide to us for our

submission

What differences in requirements are there across the targeted countries

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

Compare Detailed Requirements

Multiple countriesselected

View Compare Detailed Requirements active

19Use Case 03 ndash Flagging high level differences in requirements across in

multiple countries

A pharmaceutical client is registering a new product in Brazil

Colombia and Peru and is contracting the final release and

packaging to a local manufacturer

What high level differences in requirements are there across the targeted countries

Compare Summary Requirements

Multiple countriesselected

View Compare Summary Requirements active

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

4

Sustainable Development Goal 38 of the United Nations-promotion of health through expanded access to quality assured medicines

Health for Allhellip

Manufacturing controls amp Quality assurance systems are the foundation for assuring quality products

Challenge is the easy access of up-to-date manufacturing control requirements- LMIC countries

- Lower and middle income countries

5

Global burden of diseases-

bull Malaria ndash 90 of the cases were in the WHO African Region followed by the WHO South-East Asia Region (7) and the WHO Eastern Mediterranean Region (2) Of the 91 countries reporting indigenous malaria cases in 2016 15 countries ndash all in sub-Saharan Africa except India ndash carried 80 of the global malaria burden

bull Tuberculosis- 86 million new cases

bull HIV- 80 of people living with HIV

Regulatory Challenges-

bull Navigation of regulatory requirements

bull Location and Interpretation of CMC requirements

bull Variations in regional requirements

bull Varying levels of regulatory enforcement maturity

bull Lack of awareness

Why LMICs

6

Many manufacturersrsquo use regulatory programmes such as WHO Prequalification Programme (PQ) and USFDArsquos PEPFAR tentative approval pathway However individual countryrsquos approval through National Regulatory Authority might be required to launch the drugs in country of interest to ensure that the products entering these markets are safe efficacious and meet the requisite manufacturing quality standards and comply to importexport requirements

Challenges faced by manufacturers in product development partnerships which might lead to delay in product launch

bull Stability Studies

bull GMP Inspections

bull Labelling

bull Packaging

bull In country QC testing

bull National Regulatory Authority Approval

bull Reference product selection

Regulatory Approval Processes- Challenges and Implications

The lack of visibility of regulatory requirements can result in higher costs and patientsrsquo delayed access to drugs

$15 million

7

The importance of CMC activities - By the numbers

8

bull Lack of CMC understanding for markets of interest can

bull Discourage companies from pursuing new markets

bull Lead to investing significant time and money in pursuing projects that are not a good fit

bull Lock companies into suboptimal partnerships

bull Increase the cost of market entry

bull Without proper understanding of CMC requirements companies risk spending significant amounts of money on unnecessary (or incorrect) testing and transportation options

bull Delay market entry

bull Potentially lead to product rejections on the border after approval

In the Generics Industry Speed and Efficiency Are Paramount

There is a definitive need to make sure that you have access to the highest quality and most up to date CMC information to avoid submission delays and successfully bring a drug to market to avoid extended timelines unplanned costs and loss of forecasted revenue

9

Common Challenges for CMC Professionals

bull Efficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations

bull Select countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Choose the optimal path to market by pinpointing potential approval pathways

bull Develop CMC strategies to balance cost time and quality risk

bull Fully understand requirements around testing and manufacturing before making decisions around who to partner with

Cortellis CMC Intelligence

Donrsquot let lack of regulatory intelligence get in the way of your success

10

ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations

bull Access country-specific reports comprising of

bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC

requirementsbull Procedure Visualizationsbull Registration Pathways

11

Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices

bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs

12

Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways

bull Access detailed workflows for regulatory submission procedures

bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification

13

Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk

bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business

bull Understand detailed requirements to better develop your CMC strategy

14

Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with

bull Understand official regulations and local practices of potential partner company locations

bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy

Use Cases

16

❶

❷

❸

❶

bull Select multiple countries of interestbull Drill down appropriate requirements view

Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form

❹

❹

❸

View Reportsbull View country-specific reports comprising

bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources

❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries

Cortellis CMC Intelligence Workflow

17

Use Case 01 ndash Registering a new product in a single country

A pharmaceutical client is registering a new product in Brazil and is

contracting the final release and packaging to a local manufacturer

What documents does the local packager need to provide to us for our submission

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

View Report ndash Detailed Requirements

Brazil selected

View Report active

18Use Case 02 ndash Registering a new product in multiple countries

A pharmaceutical client is registering a new product in Brazil Colombia

and Peru and is contracting the final release and packaging to a local

manufacturer

What documents does the local packager need to provide to us for our

submission

What differences in requirements are there across the targeted countries

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

Compare Detailed Requirements

Multiple countriesselected

View Compare Detailed Requirements active

19Use Case 03 ndash Flagging high level differences in requirements across in

multiple countries

A pharmaceutical client is registering a new product in Brazil

Colombia and Peru and is contracting the final release and

packaging to a local manufacturer

What high level differences in requirements are there across the targeted countries

Compare Summary Requirements

Multiple countriesselected

View Compare Summary Requirements active

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

5

Global burden of diseases-

bull Malaria ndash 90 of the cases were in the WHO African Region followed by the WHO South-East Asia Region (7) and the WHO Eastern Mediterranean Region (2) Of the 91 countries reporting indigenous malaria cases in 2016 15 countries ndash all in sub-Saharan Africa except India ndash carried 80 of the global malaria burden

bull Tuberculosis- 86 million new cases

bull HIV- 80 of people living with HIV

Regulatory Challenges-

bull Navigation of regulatory requirements

bull Location and Interpretation of CMC requirements

bull Variations in regional requirements

bull Varying levels of regulatory enforcement maturity

bull Lack of awareness

Why LMICs

6

Many manufacturersrsquo use regulatory programmes such as WHO Prequalification Programme (PQ) and USFDArsquos PEPFAR tentative approval pathway However individual countryrsquos approval through National Regulatory Authority might be required to launch the drugs in country of interest to ensure that the products entering these markets are safe efficacious and meet the requisite manufacturing quality standards and comply to importexport requirements

Challenges faced by manufacturers in product development partnerships which might lead to delay in product launch

bull Stability Studies

bull GMP Inspections

bull Labelling

bull Packaging

bull In country QC testing

bull National Regulatory Authority Approval

bull Reference product selection

Regulatory Approval Processes- Challenges and Implications

The lack of visibility of regulatory requirements can result in higher costs and patientsrsquo delayed access to drugs

$15 million

7

The importance of CMC activities - By the numbers

8

bull Lack of CMC understanding for markets of interest can

bull Discourage companies from pursuing new markets

bull Lead to investing significant time and money in pursuing projects that are not a good fit

bull Lock companies into suboptimal partnerships

bull Increase the cost of market entry

bull Without proper understanding of CMC requirements companies risk spending significant amounts of money on unnecessary (or incorrect) testing and transportation options

bull Delay market entry

bull Potentially lead to product rejections on the border after approval

In the Generics Industry Speed and Efficiency Are Paramount

There is a definitive need to make sure that you have access to the highest quality and most up to date CMC information to avoid submission delays and successfully bring a drug to market to avoid extended timelines unplanned costs and loss of forecasted revenue

9

Common Challenges for CMC Professionals

bull Efficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations

bull Select countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Choose the optimal path to market by pinpointing potential approval pathways

bull Develop CMC strategies to balance cost time and quality risk

bull Fully understand requirements around testing and manufacturing before making decisions around who to partner with

Cortellis CMC Intelligence

Donrsquot let lack of regulatory intelligence get in the way of your success

10

ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations

bull Access country-specific reports comprising of

bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC

requirementsbull Procedure Visualizationsbull Registration Pathways

11

Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices

bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs

12

Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways

bull Access detailed workflows for regulatory submission procedures

bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification

13

Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk

bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business

bull Understand detailed requirements to better develop your CMC strategy

14

Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with

bull Understand official regulations and local practices of potential partner company locations

bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy

Use Cases

16

❶

❷

❸

❶

bull Select multiple countries of interestbull Drill down appropriate requirements view

Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form

❹

❹

❸

View Reportsbull View country-specific reports comprising

bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources

❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries

Cortellis CMC Intelligence Workflow

17

Use Case 01 ndash Registering a new product in a single country

A pharmaceutical client is registering a new product in Brazil and is

contracting the final release and packaging to a local manufacturer

What documents does the local packager need to provide to us for our submission

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

View Report ndash Detailed Requirements

Brazil selected

View Report active

18Use Case 02 ndash Registering a new product in multiple countries

A pharmaceutical client is registering a new product in Brazil Colombia

and Peru and is contracting the final release and packaging to a local

manufacturer

What documents does the local packager need to provide to us for our

submission

What differences in requirements are there across the targeted countries

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

Compare Detailed Requirements

Multiple countriesselected

View Compare Detailed Requirements active

19Use Case 03 ndash Flagging high level differences in requirements across in

multiple countries

A pharmaceutical client is registering a new product in Brazil

Colombia and Peru and is contracting the final release and

packaging to a local manufacturer

What high level differences in requirements are there across the targeted countries

Compare Summary Requirements

Multiple countriesselected

View Compare Summary Requirements active

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

6

Many manufacturersrsquo use regulatory programmes such as WHO Prequalification Programme (PQ) and USFDArsquos PEPFAR tentative approval pathway However individual countryrsquos approval through National Regulatory Authority might be required to launch the drugs in country of interest to ensure that the products entering these markets are safe efficacious and meet the requisite manufacturing quality standards and comply to importexport requirements

Challenges faced by manufacturers in product development partnerships which might lead to delay in product launch

bull Stability Studies

bull GMP Inspections

bull Labelling

bull Packaging

bull In country QC testing

bull National Regulatory Authority Approval

bull Reference product selection

Regulatory Approval Processes- Challenges and Implications

The lack of visibility of regulatory requirements can result in higher costs and patientsrsquo delayed access to drugs

$15 million

7

The importance of CMC activities - By the numbers

8

bull Lack of CMC understanding for markets of interest can

bull Discourage companies from pursuing new markets

bull Lead to investing significant time and money in pursuing projects that are not a good fit

bull Lock companies into suboptimal partnerships

bull Increase the cost of market entry

bull Without proper understanding of CMC requirements companies risk spending significant amounts of money on unnecessary (or incorrect) testing and transportation options

bull Delay market entry

bull Potentially lead to product rejections on the border after approval

In the Generics Industry Speed and Efficiency Are Paramount

There is a definitive need to make sure that you have access to the highest quality and most up to date CMC information to avoid submission delays and successfully bring a drug to market to avoid extended timelines unplanned costs and loss of forecasted revenue

9

Common Challenges for CMC Professionals

bull Efficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations

bull Select countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Choose the optimal path to market by pinpointing potential approval pathways

bull Develop CMC strategies to balance cost time and quality risk

bull Fully understand requirements around testing and manufacturing before making decisions around who to partner with

Cortellis CMC Intelligence

Donrsquot let lack of regulatory intelligence get in the way of your success

10

ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations

bull Access country-specific reports comprising of

bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC

requirementsbull Procedure Visualizationsbull Registration Pathways

11

Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices

bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs

12

Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways

bull Access detailed workflows for regulatory submission procedures

bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification

13

Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk

bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business

bull Understand detailed requirements to better develop your CMC strategy

14

Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with

bull Understand official regulations and local practices of potential partner company locations

bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy

Use Cases

16

❶

❷

❸

❶

bull Select multiple countries of interestbull Drill down appropriate requirements view

Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form

❹

❹

❸

View Reportsbull View country-specific reports comprising

bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources

❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries

Cortellis CMC Intelligence Workflow

17

Use Case 01 ndash Registering a new product in a single country

A pharmaceutical client is registering a new product in Brazil and is

contracting the final release and packaging to a local manufacturer

What documents does the local packager need to provide to us for our submission

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

View Report ndash Detailed Requirements

Brazil selected

View Report active

18Use Case 02 ndash Registering a new product in multiple countries

A pharmaceutical client is registering a new product in Brazil Colombia

and Peru and is contracting the final release and packaging to a local

manufacturer

What documents does the local packager need to provide to us for our

submission

What differences in requirements are there across the targeted countries

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

Compare Detailed Requirements

Multiple countriesselected

View Compare Detailed Requirements active

19Use Case 03 ndash Flagging high level differences in requirements across in

multiple countries

A pharmaceutical client is registering a new product in Brazil

Colombia and Peru and is contracting the final release and

packaging to a local manufacturer

What high level differences in requirements are there across the targeted countries

Compare Summary Requirements

Multiple countriesselected

View Compare Summary Requirements active

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

7

The importance of CMC activities - By the numbers

8

bull Lack of CMC understanding for markets of interest can

bull Discourage companies from pursuing new markets

bull Lead to investing significant time and money in pursuing projects that are not a good fit

bull Lock companies into suboptimal partnerships

bull Increase the cost of market entry

bull Without proper understanding of CMC requirements companies risk spending significant amounts of money on unnecessary (or incorrect) testing and transportation options

bull Delay market entry

bull Potentially lead to product rejections on the border after approval

In the Generics Industry Speed and Efficiency Are Paramount

There is a definitive need to make sure that you have access to the highest quality and most up to date CMC information to avoid submission delays and successfully bring a drug to market to avoid extended timelines unplanned costs and loss of forecasted revenue

9

Common Challenges for CMC Professionals

bull Efficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations

bull Select countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Choose the optimal path to market by pinpointing potential approval pathways

bull Develop CMC strategies to balance cost time and quality risk

bull Fully understand requirements around testing and manufacturing before making decisions around who to partner with

Cortellis CMC Intelligence

Donrsquot let lack of regulatory intelligence get in the way of your success

10

ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations

bull Access country-specific reports comprising of

bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC

requirementsbull Procedure Visualizationsbull Registration Pathways

11

Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices

bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs

12

Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways

bull Access detailed workflows for regulatory submission procedures

bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification

13

Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk

bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business

bull Understand detailed requirements to better develop your CMC strategy

14

Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with

bull Understand official regulations and local practices of potential partner company locations

bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy

Use Cases

16

❶

❷

❸

❶

bull Select multiple countries of interestbull Drill down appropriate requirements view

Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form

❹

❹

❸

View Reportsbull View country-specific reports comprising

bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources

❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries

Cortellis CMC Intelligence Workflow

17

Use Case 01 ndash Registering a new product in a single country

A pharmaceutical client is registering a new product in Brazil and is

contracting the final release and packaging to a local manufacturer

What documents does the local packager need to provide to us for our submission

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

View Report ndash Detailed Requirements

Brazil selected

View Report active

18Use Case 02 ndash Registering a new product in multiple countries

A pharmaceutical client is registering a new product in Brazil Colombia

and Peru and is contracting the final release and packaging to a local

manufacturer

What documents does the local packager need to provide to us for our

submission

What differences in requirements are there across the targeted countries

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

Compare Detailed Requirements

Multiple countriesselected

View Compare Detailed Requirements active

19Use Case 03 ndash Flagging high level differences in requirements across in

multiple countries

A pharmaceutical client is registering a new product in Brazil

Colombia and Peru and is contracting the final release and

packaging to a local manufacturer

What high level differences in requirements are there across the targeted countries

Compare Summary Requirements

Multiple countriesselected

View Compare Summary Requirements active

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

8

bull Lack of CMC understanding for markets of interest can

bull Discourage companies from pursuing new markets

bull Lead to investing significant time and money in pursuing projects that are not a good fit

bull Lock companies into suboptimal partnerships

bull Increase the cost of market entry

bull Without proper understanding of CMC requirements companies risk spending significant amounts of money on unnecessary (or incorrect) testing and transportation options

bull Delay market entry

bull Potentially lead to product rejections on the border after approval

In the Generics Industry Speed and Efficiency Are Paramount

There is a definitive need to make sure that you have access to the highest quality and most up to date CMC information to avoid submission delays and successfully bring a drug to market to avoid extended timelines unplanned costs and loss of forecasted revenue

9

Common Challenges for CMC Professionals

bull Efficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations

bull Select countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Choose the optimal path to market by pinpointing potential approval pathways

bull Develop CMC strategies to balance cost time and quality risk

bull Fully understand requirements around testing and manufacturing before making decisions around who to partner with

Cortellis CMC Intelligence

Donrsquot let lack of regulatory intelligence get in the way of your success

10

ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations

bull Access country-specific reports comprising of

bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC

requirementsbull Procedure Visualizationsbull Registration Pathways

11

Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices

bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs

12

Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways

bull Access detailed workflows for regulatory submission procedures

bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification

13

Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk

bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business

bull Understand detailed requirements to better develop your CMC strategy

14

Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with

bull Understand official regulations and local practices of potential partner company locations

bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy

Use Cases

16

❶

❷

❸

❶

bull Select multiple countries of interestbull Drill down appropriate requirements view

Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form

❹

❹

❸

View Reportsbull View country-specific reports comprising

bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources

❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries

Cortellis CMC Intelligence Workflow

17

Use Case 01 ndash Registering a new product in a single country

A pharmaceutical client is registering a new product in Brazil and is

contracting the final release and packaging to a local manufacturer

What documents does the local packager need to provide to us for our submission

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

View Report ndash Detailed Requirements

Brazil selected

View Report active

18Use Case 02 ndash Registering a new product in multiple countries

A pharmaceutical client is registering a new product in Brazil Colombia

and Peru and is contracting the final release and packaging to a local

manufacturer

What documents does the local packager need to provide to us for our

submission

What differences in requirements are there across the targeted countries

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

Compare Detailed Requirements

Multiple countriesselected

View Compare Detailed Requirements active

19Use Case 03 ndash Flagging high level differences in requirements across in

multiple countries

A pharmaceutical client is registering a new product in Brazil

Colombia and Peru and is contracting the final release and

packaging to a local manufacturer

What high level differences in requirements are there across the targeted countries

Compare Summary Requirements

Multiple countriesselected

View Compare Summary Requirements active

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

9

Common Challenges for CMC Professionals

bull Efficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations

bull Select countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Choose the optimal path to market by pinpointing potential approval pathways

bull Develop CMC strategies to balance cost time and quality risk

bull Fully understand requirements around testing and manufacturing before making decisions around who to partner with

Cortellis CMC Intelligence

Donrsquot let lack of regulatory intelligence get in the way of your success

10

ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations

bull Access country-specific reports comprising of

bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC

requirementsbull Procedure Visualizationsbull Registration Pathways

11

Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices

bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs

12

Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways

bull Access detailed workflows for regulatory submission procedures

bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification

13

Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk

bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business

bull Understand detailed requirements to better develop your CMC strategy

14

Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with

bull Understand official regulations and local practices of potential partner company locations

bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy

Use Cases

16

❶

❷

❸

❶

bull Select multiple countries of interestbull Drill down appropriate requirements view

Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form

❹

❹

❸

View Reportsbull View country-specific reports comprising

bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources

❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries

Cortellis CMC Intelligence Workflow

17

Use Case 01 ndash Registering a new product in a single country

A pharmaceutical client is registering a new product in Brazil and is

contracting the final release and packaging to a local manufacturer

What documents does the local packager need to provide to us for our submission

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

View Report ndash Detailed Requirements

Brazil selected

View Report active

18Use Case 02 ndash Registering a new product in multiple countries

A pharmaceutical client is registering a new product in Brazil Colombia

and Peru and is contracting the final release and packaging to a local

manufacturer

What documents does the local packager need to provide to us for our

submission

What differences in requirements are there across the targeted countries

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

Compare Detailed Requirements

Multiple countriesselected

View Compare Detailed Requirements active

19Use Case 03 ndash Flagging high level differences in requirements across in

multiple countries

A pharmaceutical client is registering a new product in Brazil

Colombia and Peru and is contracting the final release and

packaging to a local manufacturer

What high level differences in requirements are there across the targeted countries

Compare Summary Requirements

Multiple countriesselected

View Compare Summary Requirements active

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

10

ComplianceEfficiently track CMC requirements in countries of interest to ensure compliance with evolving regulations

bull Access country-specific reports comprising of

bull Key Requirementsbull Procedural and administrative requirementsbull Drug substance amp Drug Product CMC

requirementsbull Procedure Visualizationsbull Registration Pathways

11

Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices

bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs

12

Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways

bull Access detailed workflows for regulatory submission procedures

bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification

13

Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk

bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business

bull Understand detailed requirements to better develop your CMC strategy

14

Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with

bull Understand official regulations and local practices of potential partner company locations

bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy

Use Cases

16

❶

❷

❸

❶

bull Select multiple countries of interestbull Drill down appropriate requirements view

Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form

❹

❹

❸

View Reportsbull View country-specific reports comprising

bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources

❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries

Cortellis CMC Intelligence Workflow

17

Use Case 01 ndash Registering a new product in a single country

A pharmaceutical client is registering a new product in Brazil and is

contracting the final release and packaging to a local manufacturer

What documents does the local packager need to provide to us for our submission

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

View Report ndash Detailed Requirements

Brazil selected

View Report active

18Use Case 02 ndash Registering a new product in multiple countries

A pharmaceutical client is registering a new product in Brazil Colombia

and Peru and is contracting the final release and packaging to a local

manufacturer

What documents does the local packager need to provide to us for our

submission

What differences in requirements are there across the targeted countries

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

Compare Detailed Requirements

Multiple countriesselected

View Compare Detailed Requirements active

19Use Case 03 ndash Flagging high level differences in requirements across in

multiple countries

A pharmaceutical client is registering a new product in Brazil

Colombia and Peru and is contracting the final release and

packaging to a local manufacturer

What high level differences in requirements are there across the targeted countries

Compare Summary Requirements

Multiple countriesselected

View Compare Summary Requirements active

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

11

Country SelectionSelect countries that best fit your capabilities by understanding specific regional requirements for manufacturing trials or distribution

bull Visually compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practices

bull Refine results by applying indexing such as product type and pharmaceutical form to target requirements specific to your drugs

12

Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways

bull Access detailed workflows for regulatory submission procedures

bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification

13

Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk

bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business

bull Understand detailed requirements to better develop your CMC strategy

14

Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with

bull Understand official regulations and local practices of potential partner company locations

bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy

Use Cases

16

❶

❷

❸

❶

bull Select multiple countries of interestbull Drill down appropriate requirements view

Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form

❹

❹

❸

View Reportsbull View country-specific reports comprising

bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources

❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries

Cortellis CMC Intelligence Workflow

17

Use Case 01 ndash Registering a new product in a single country

A pharmaceutical client is registering a new product in Brazil and is

contracting the final release and packaging to a local manufacturer

What documents does the local packager need to provide to us for our submission

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

View Report ndash Detailed Requirements

Brazil selected

View Report active

18Use Case 02 ndash Registering a new product in multiple countries

A pharmaceutical client is registering a new product in Brazil Colombia

and Peru and is contracting the final release and packaging to a local

manufacturer

What documents does the local packager need to provide to us for our

submission

What differences in requirements are there across the targeted countries

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

Compare Detailed Requirements

Multiple countriesselected

View Compare Detailed Requirements active

19Use Case 03 ndash Flagging high level differences in requirements across in

multiple countries

A pharmaceutical client is registering a new product in Brazil

Colombia and Peru and is contracting the final release and

packaging to a local manufacturer

What high level differences in requirements are there across the targeted countries

Compare Summary Requirements

Multiple countriesselected

View Compare Summary Requirements active

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

12

Regulatory StrategyChoose the optimal path to market by pinpointing potential approval pathways

bull Access detailed workflows for regulatory submission procedures

bull Understand details on accelerated procedures regulatory authority involvement and WHO prequalification

13

Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk

bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business

bull Understand detailed requirements to better develop your CMC strategy

14

Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with

bull Understand official regulations and local practices of potential partner company locations

bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy

Use Cases

16

❶

❷

❸

❶

bull Select multiple countries of interestbull Drill down appropriate requirements view

Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form

❹

❹

❸

View Reportsbull View country-specific reports comprising

bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources

❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries

Cortellis CMC Intelligence Workflow

17

Use Case 01 ndash Registering a new product in a single country

A pharmaceutical client is registering a new product in Brazil and is

contracting the final release and packaging to a local manufacturer

What documents does the local packager need to provide to us for our submission

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

View Report ndash Detailed Requirements

Brazil selected

View Report active

18Use Case 02 ndash Registering a new product in multiple countries

A pharmaceutical client is registering a new product in Brazil Colombia

and Peru and is contracting the final release and packaging to a local

manufacturer

What documents does the local packager need to provide to us for our

submission

What differences in requirements are there across the targeted countries

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

Compare Detailed Requirements

Multiple countriesselected

View Compare Detailed Requirements active

19Use Case 03 ndash Flagging high level differences in requirements across in

multiple countries

A pharmaceutical client is registering a new product in Brazil

Colombia and Peru and is contracting the final release and

packaging to a local manufacturer

What high level differences in requirements are there across the targeted countries

Compare Summary Requirements

Multiple countriesselected

View Compare Summary Requirements active

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

13

Regulatory StrategyDevelop CMC strategies to balance cost time and quality risk

bull Compare CMC requirements across countries to understand differences in official and local requirements and understand which country would fit best with your business

bull Understand detailed requirements to better develop your CMC strategy

14

Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with

bull Understand official regulations and local practices of potential partner company locations

bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy

Use Cases

16

❶

❷

❸

❶

bull Select multiple countries of interestbull Drill down appropriate requirements view

Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form

❹

❹

❸

View Reportsbull View country-specific reports comprising

bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources

❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries

Cortellis CMC Intelligence Workflow

17

Use Case 01 ndash Registering a new product in a single country

A pharmaceutical client is registering a new product in Brazil and is

contracting the final release and packaging to a local manufacturer

What documents does the local packager need to provide to us for our submission

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

View Report ndash Detailed Requirements

Brazil selected

View Report active

18Use Case 02 ndash Registering a new product in multiple countries

A pharmaceutical client is registering a new product in Brazil Colombia

and Peru and is contracting the final release and packaging to a local

manufacturer

What documents does the local packager need to provide to us for our

submission

What differences in requirements are there across the targeted countries

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

Compare Detailed Requirements

Multiple countriesselected

View Compare Detailed Requirements active

19Use Case 03 ndash Flagging high level differences in requirements across in

multiple countries

A pharmaceutical client is registering a new product in Brazil

Colombia and Peru and is contracting the final release and

packaging to a local manufacturer

What high level differences in requirements are there across the targeted countries

Compare Summary Requirements

Multiple countriesselected

View Compare Summary Requirements active

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

14

Partner SelectionFully understand requirements around testing and manufacturing before making decisions around who to partner with

bull Understand official regulations and local practices of potential partner company locations

bull Compare requirements across countries to choose ideal partner based on their capabilities and your strategy

Use Cases

16

❶

❷

❸

❶

bull Select multiple countries of interestbull Drill down appropriate requirements view

Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form

❹

❹

❸

View Reportsbull View country-specific reports comprising

bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources

❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries

Cortellis CMC Intelligence Workflow

17

Use Case 01 ndash Registering a new product in a single country

A pharmaceutical client is registering a new product in Brazil and is

contracting the final release and packaging to a local manufacturer

What documents does the local packager need to provide to us for our submission

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

View Report ndash Detailed Requirements

Brazil selected

View Report active

18Use Case 02 ndash Registering a new product in multiple countries

A pharmaceutical client is registering a new product in Brazil Colombia

and Peru and is contracting the final release and packaging to a local

manufacturer

What documents does the local packager need to provide to us for our

submission

What differences in requirements are there across the targeted countries

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

Compare Detailed Requirements

Multiple countriesselected

View Compare Detailed Requirements active

19Use Case 03 ndash Flagging high level differences in requirements across in

multiple countries

A pharmaceutical client is registering a new product in Brazil

Colombia and Peru and is contracting the final release and

packaging to a local manufacturer

What high level differences in requirements are there across the targeted countries

Compare Summary Requirements

Multiple countriesselected

View Compare Summary Requirements active

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

Use Cases

16

❶

❷

❸

❶

bull Select multiple countries of interestbull Drill down appropriate requirements view

Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form

❹

❹

❸

View Reportsbull View country-specific reports comprising

bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources

❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries

Cortellis CMC Intelligence Workflow

17

Use Case 01 ndash Registering a new product in a single country

A pharmaceutical client is registering a new product in Brazil and is

contracting the final release and packaging to a local manufacturer

What documents does the local packager need to provide to us for our submission

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

View Report ndash Detailed Requirements

Brazil selected

View Report active

18Use Case 02 ndash Registering a new product in multiple countries

A pharmaceutical client is registering a new product in Brazil Colombia

and Peru and is contracting the final release and packaging to a local

manufacturer

What documents does the local packager need to provide to us for our

submission

What differences in requirements are there across the targeted countries

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

Compare Detailed Requirements

Multiple countriesselected

View Compare Detailed Requirements active

19Use Case 03 ndash Flagging high level differences in requirements across in

multiple countries

A pharmaceutical client is registering a new product in Brazil

Colombia and Peru and is contracting the final release and

packaging to a local manufacturer

What high level differences in requirements are there across the targeted countries

Compare Summary Requirements

Multiple countriesselected

View Compare Summary Requirements active

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

16

❶

❷

❸

❶

bull Select multiple countries of interestbull Drill down appropriate requirements view

Compare Detailed Requirementsbull Select specific ICH eCTD requirements bull Compare detailed national regulatory authority-derived Official Regulations and local expertise-based Local Practicesbull Refine results by applying indexing such as product type and pharmaceutical form

❹

❹

❸

View Reportsbull View country-specific reports comprising

bull Key Factsbull Key Requirementsbull Procedure Visualizationsbull Detailed Requirementsbull Sources

❷ Compare Summary Requirementsbull Select requirements based on the ICH eCTDbull Use visual comparisons to identify differences in requirements across selected countries

Cortellis CMC Intelligence Workflow

17

Use Case 01 ndash Registering a new product in a single country

A pharmaceutical client is registering a new product in Brazil and is

contracting the final release and packaging to a local manufacturer

What documents does the local packager need to provide to us for our submission

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

View Report ndash Detailed Requirements

Brazil selected

View Report active

18Use Case 02 ndash Registering a new product in multiple countries

A pharmaceutical client is registering a new product in Brazil Colombia

and Peru and is contracting the final release and packaging to a local

manufacturer

What documents does the local packager need to provide to us for our

submission

What differences in requirements are there across the targeted countries

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

Compare Detailed Requirements

Multiple countriesselected

View Compare Detailed Requirements active

19Use Case 03 ndash Flagging high level differences in requirements across in

multiple countries

A pharmaceutical client is registering a new product in Brazil

Colombia and Peru and is contracting the final release and

packaging to a local manufacturer

What high level differences in requirements are there across the targeted countries

Compare Summary Requirements

Multiple countriesselected

View Compare Summary Requirements active

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

17

Use Case 01 ndash Registering a new product in a single country

A pharmaceutical client is registering a new product in Brazil and is

contracting the final release and packaging to a local manufacturer

What documents does the local packager need to provide to us for our submission

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

View Report ndash Detailed Requirements

Brazil selected

View Report active

18Use Case 02 ndash Registering a new product in multiple countries

A pharmaceutical client is registering a new product in Brazil Colombia

and Peru and is contracting the final release and packaging to a local

manufacturer

What documents does the local packager need to provide to us for our

submission

What differences in requirements are there across the targeted countries

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

Compare Detailed Requirements

Multiple countriesselected

View Compare Detailed Requirements active

19Use Case 03 ndash Flagging high level differences in requirements across in

multiple countries

A pharmaceutical client is registering a new product in Brazil

Colombia and Peru and is contracting the final release and

packaging to a local manufacturer

What high level differences in requirements are there across the targeted countries

Compare Summary Requirements

Multiple countriesselected

View Compare Summary Requirements active

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

18Use Case 02 ndash Registering a new product in multiple countries

A pharmaceutical client is registering a new product in Brazil Colombia

and Peru and is contracting the final release and packaging to a local

manufacturer

What documents does the local packager need to provide to us for our

submission

What differences in requirements are there across the targeted countries

How a manufacturer protects and packages their product must be demonstrated by sufficient documentation and

testing of said materials

Compare Detailed Requirements

Multiple countriesselected

View Compare Detailed Requirements active

19Use Case 03 ndash Flagging high level differences in requirements across in

multiple countries

A pharmaceutical client is registering a new product in Brazil

Colombia and Peru and is contracting the final release and

packaging to a local manufacturer

What high level differences in requirements are there across the targeted countries

Compare Summary Requirements

Multiple countriesselected

View Compare Summary Requirements active

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

19Use Case 03 ndash Flagging high level differences in requirements across in

multiple countries

A pharmaceutical client is registering a new product in Brazil

Colombia and Peru and is contracting the final release and

packaging to a local manufacturer

What high level differences in requirements are there across the targeted countries

Compare Summary Requirements

Multiple countriesselected

View Compare Summary Requirements active

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

20

Your partner for the entire innovation journey

Discovery amp Translational Science

Setting the RampD Direction

Regulatory Compliance

Clinical Trials

Business Development amp Licensing Sourcing amp

Manufacturing

IP Protection

Life Science Solutions

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom

Dr Mandakini Goel|Sr Solution Consultant|MandakinigoelClarivatecom| Clarivatecom