Responsibility of MYdossier.in for CTD dossier preparation
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MYdossier.in Dossier Consultancy Divis ion, Zodiac Pharma Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, (On Sate Highway No 219) Madanapalle -517 325, Andhra Pradesh India Website:- http://www.mydossier.in ; Email:- [email protected] Responsibility of MYdossier.in for CTD dossier preparation 1. We will follow latest format of registration guideline documents 2. We will use correct and appropriate information to prepare dossier 3. We will follow latest specification for API, FP and RM 4. We will take care of complete MOH queries (if raise during MOH registration) 5. NO additional consultancy fees will charge for solving MOH queries How we are different from others for CTD dossier preparation 1. Dedicated dossier developing facility in 30,000 sft 2. Most reasonable price with highest quality 3. Post sale support (free help for solving MOH queries – if raised during registration) 4. We know what to do and what not to do during CTD dossier preparation 5. We always take care of business interest of our clients
Transcript of Responsibility of MYdossier.in for CTD dossier preparation
MYdossier.in Dossier Consultancy Divis ion, Zodiac Pharma
Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, (On Sate Highway No 219)
Madanapalle -517 325, Andhra Pradesh India
Website:- http://www.mydossier.in; Email:- [email protected]
Responsibility of MYdossier.in for CTD dossier preparation
1. We will follow latest format of registration guideline documents
2. We will use correct and appropriate information to prepare dossier
3. We will follow latest specification for API, FP and RM
4. We will take care of complete MOH queries (if raise during MOH registration)
5. NO additional consultancy fees will charge for solving MOH queries
How we are different from others for CTD dossier preparation
1. Dedicated dossier developing facility in 30 ,000 sft
2. Most reasonable price with highest quality
3. Post sale support (free help for solving MOH queries – if raised during registration)
4. We know what to do and what not to do during CTD dossier preparation
5. We always take care of business interest of our clients
MYdossier.in Dossier Consultancy Divis ion, Zodiac Pharma
Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, (On Sate Highway No 219)
Madanapalle -517 325, Andhra Pradesh India
Website:- http://www.mydossier.in; Email:- [email protected]
About MYDossier.in
MYdossier (Division of Zodiac Pharma) is an Indian based Export dossier registration consulting firm. We offer a wide range of
services in the areas of in the areas of Pharma dossier sale, regulatory affairs, handling MOH inquiry, and dossier training for small
to medium size pharmaceutical companies to help them to overcome the challenges within the rapidly evolving global pharmaceutical
market.
Mission: "To become a Research-based International Regulatory Affairs and dossier development centre"
Core Values : We are driven by a desire to excel and exceed customer expectations, provide a joyous working environment for our
people and empower them to think big and set ambitious goals. We want to achieve all this in an environment that promotes integrity.
Vision: "Achieving significant business in generic product dossier consultancy with a strong presence in non-regulated and semi-
regulated market (Asia, Africa, CIS, Latin America)"
Founder, CEO & Chief consultant – Mr. Tara chand Tak
All dossiers are prepared under guidance and observation of Mr. Tara chand Tak
He is also worked as regulatory affairs consultant for Global assessment of VMP registration
regulations (World Bank Group project tilted EBA).
His foresightedness can be well showed by his endeavors which area from Pharma dossier
sale, regulatory affairs, handling MOH inquiry, and dossier training for small to medium size
pharmaceutical companies to help them to overcome the challenges within the rapidly evolving
global pharmaceutical market.. He drives the company's vision, strategy and growth as it
provides interesting and unique ways for client and learner to serve their purpose.
MYdossier.in Dossier Consultancy Divis ion, Zodiac Pharma
Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, (On Sate Highway No 219)
Madanapalle -517 325, Andhra Pradesh India
Website:- http://www.mydossier.in; Email:- [email protected]
He did his schooling from Jawahar Navodaya Vidyalaya (Pali) Rajasthan. He did his B.Pharm & M.Pharm from Manipal collage of
Pharmaceutical Sciences, Manipal University, Udupi, Karnataka. He also did certificate course in intellectual property rights from
World Intellectual Property Organization (WIPO), Geneva, Switzerland. After his postgraduate, he worked on the post of Executive in
Pharma MNC companies at Bangalore and Hyderabad. His core areas of during job were in dossier writing, global dossier
management and international marketing. During that period, he got opportunity to work with global leader – Pfizer, Ranbaxy,
Sandoze, Teva, Lupin, DRL, Mylan, Stride arcolabs, Apotex Canada etc.
More than 2000 CTD and ASEAN CTD dossier prepared under his guidance in past 5 years. He having more than 9
years experience in CTD dossier, ASEAN CTD and ROW dossiers.
YES WE CAN WE ARE MYdossier.in
India's MOST
RECOMMENDED dossier
consultancy
MYdossier.in Dossier Consultancy Divis ion, Zodiac Pharma
Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, (On Sate Highway No 219)
Madanapalle -517 325, Andhra Pradesh India
Website:- http://www.mydossier.in; Email:- [email protected]
Key Feature
CTD dossiers will compliance with current pharmacopeia
Process validation Stability data and COA will be complete
All MoH queries will handled by us
CTD DOSSIER (As per ICH / EU / ROW CTD format)
# Heading Description
MODULE 1 Administrative Information and
Prescribing Information
Provided/ Prepared / Compile / Drafted by MYDossier.in
1.0 Cover Letter It need to prepared by Applicant at the time of submission
1.1 Comprehensive table of contents Provided/ Prepared / Compile / Drafted by MYDossier.in
1.2 Application forms It need to prepared by Applicant at the time of submission or Application form need to send us for drafting
1.3 Product information
1.3.1 Summary of Product Characteristics Provided/ Prepared / Compile / Drafted by MYDossier.in
1.3.2 Proposals for Samples/mockups of Packaging, Labeling, Package Leaflet/Insert
PIL/Pack insert will Provided/ Prepared / Compile / Drafted by MYDossier.in
1.3.3 SPC’s already approved in other countries medical Need to provided by applicant (if any)
1.4 Information about experts Resume need to send us
1.5 Certificates and other information Manufacturer need to arrange
MODULE 2 Common Technical Document
Summaries
Provided/ Prepared / Compile / Drafted by MYDossier.in
2.1 Table of content Provided/ Prepared / Compile / Drafted by MYDossier.in
2.2 CTD Introduction Provided/ Prepared / Compile / Drafted by MYDossier.in
MYdossier.in Dossier Consultancy Divis ion, Zodiac Pharma
Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, (On Sate Highway No 219)
Madanapalle -517 325, Andhra Pradesh India
Website:- http://www.mydossier.in; Email:- [email protected]
2.3 Quality Overall Summary Provided/ Prepared / Compile / Drafted by MYDossier.in
2.3.S Drug Substance Provided/ Prepared / Compile / Drafted by MYDossier.in
2.3.S.1 General Information Provided/ Prepared / Compile / Drafted by MYDossier.in
2.3.S.2 Manufacture Provided/ Prepared / Compile / Drafted by MYDossier.in
2.3.S.3 Characterisation Provided/ Prepared / Compile / Drafted by MYDossier.in
2.3.S.4 Control of Drug Substance Provided/ Prepared / Compile / Drafted by MYDossier.in
2.3.S.5 Reference Standards or Materials Provided/ Prepared / Compile / Drafted by MYDossier.in
2.3.S.6 Container Closure System Provided/ Prepared / Compile / Drafted by MYDossier.in
2.3.S.7 Stability Provided/ Prepared / Compile / Drafted by MYDossier.in
2.3.P Drug Product Provided/ Prepared / Compile / Drafted by MYDossier.in
2.3.P.1 Description and Composition of the Drug Product Provided/ Prepared / Compile / Drafted by MYDossier.in
2.3.P.2 Pharmaceutical Development Provided/ Prepared / Compile / Drafted by MYDossier.in
2.3.P.3 Manufacture Provided/ Prepared / Compile / Drafted by MYDossier.in
2.3.P.4 Control of Excipients Provided/ Prepared / Compile / Drafted by MYDossier.in
2.3.P.5 Control of Drug Product Provided/ Prepared / Compile / Drafted by MYDossier.in
2.3.P.6 Reference Standards or Materials Provided/ Prepared / Compile / Drafted by MYDossier.in
2.3.P.7 Container Closure System Provided/ Prepared / Compile / Drafted by MYDossier.in
2.3.P.8 Stability Provided/ Prepared / Compile / Drafted by MYDossier.in
2.4 Nonclinical Overview Provided/ Prepared / Compile / Drafted by MYDossier.in
2.5 Clinical Overview Provided/ Prepared / Compile / Drafted by MYDossier.in
2.6 Nonclinical Written and Tabulated Summaries NOT PROVIDED
2.7 Clinical Summary NOT PROVIDED
MODULE 3 Quality Provided/ Prepared / Compile / Drafted by MYDossier.in
3.1 Table of Contents of Module 3 Provided/ Prepared / Compile / Drafted by MYDossier.in
MYdossier.in Dossier Consultancy Divis ion, Zodiac Pharma
Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, (On Sate Highway No 219)
Madanapalle -517 325, Andhra Pradesh India
Website:- http://www.mydossier.in; Email:- [email protected]
3.2 Body of Data Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S Drug Substance Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S.1 General Information Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S.1.1 Nomenclature Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S.1.2 Structure Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S.1.3 General Properties Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S.2 Manufacture Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S.2.1 Manufacturer (s) Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S.2.2 Description of Manufacturing Process and Process Controls
Provided/ Prepared / Compile / Drafted by MYDossier.in (in brief)
3.2.S.2.3 Control of Materials Not provided (as its closed part of DMF)
3.2.S.2.4 Controls of Critical Steps and Intermediates Not provided (as its closed part of DMF)
3.2.S.2.5 Process Validation and/or Evaluation Not provided (as its closed part of DMF)
3.2.S.2.6 Manufacturing Process Development Not provided (as its closed part of DMF)
3.2.S.3 Characterisation Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S.3.1 Elucidation of Structure and other Characteristics Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S.3.2 Impurities Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S.4 Control of Drug Substance Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S.4.1 Specification Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S.4.2 Analytical Procedures Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S.4.3 Validation of Analytical Procedures NOT PROVIDED
3.2.S.4.4 Batch Analyses Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S.4.5 Justification of Specification Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S.5 Reference Standards or Materials Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S.6 Container Closure System Provided/ Prepared / Compile / Drafted by MYDossier.in
MYdossier.in Dossier Consultancy Divis ion, Zodiac Pharma
Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, (On Sate Highway No 219)
Madanapalle -517 325, Andhra Pradesh India
Website:- http://www.mydossier.in; Email:- [email protected]
3.2.S.7 Stability Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S.7.1 Stability Summary and Conclusions Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S.7.2 Post-approval Stability Protocol and Stability
Commitment
Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.S.7.3 Stability Data Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P Drug Product Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.1 Description and Composition of the Drug Product Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.2 Pharmaceutical Development Provided/ Prepared / Compile / Drafted by MYDossier.in (in
brief)
3.2.P.3 Manufacture Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.3.1 Manufacturer(s) Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.3.2 Batch Formula Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.3.3 Description of Manufacturing Process and Process
Controls
Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.3.4 Controls of Critical Steps and Intermediates Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.3.5 Process Validation and/or Evaluation Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.4 Control of Excipients Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.4.1 Specifications Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.4.2 Analytical Procedures Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.4.3 Validation of Analytical Procedures Not Applicable
3.2.P.4.4 Justification of Specifications Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.4.5 Excipients of Human or Animal Origin Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.4.6 Novel Excipients Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.5 Control of Drug Product Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.5.1 Specification(s) Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.5.2 Analytical Procedures Provided/ Prepared / Compile / Drafted by MYDossier.in
MYdossier.in Dossier Consultancy Divis ion, Zodiac Pharma
Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, (On Sate Highway No 219)
Madanapalle -517 325, Andhra Pradesh India
Website:- http://www.mydossier.in; Email:- [email protected]
3.2.P.5.3 Validation of Analytical Procedures Not Provided in general (additional lab charges)
3.2.P.5.4 Batch Analyses Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.5.5 Characterisation of Impurities Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.5.6 Justification of Specification(s) Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.6 Reference Standards or Materials Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.7 Container Closure System Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.8 Stability Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.8.1 Stability Summary and Conclusion Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment
Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.8.3 Stability Data Provided/ Prepared / Compile / Drafted by MYDossier.in
3.2.P.9 Product Interchangeability equivalence evidence Provided/ Prepared / Compile / Drafted by MYDossier.in
MODULE 4 Non Clinical Study Reports Provided/ Prepared / Compile / Drafted by MYDossier.in
4.1 TABLE OF CONTENTS Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2 STUDY REPORTS Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.1 Pharmacology Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.1.1 Primary Pharmacodynamics Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.1.2 Secondary Pharmcodynamics Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.1.3 Safety Pharmacology Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.1.4 Pharmacodynamic Drug Interactions Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.2 Pharmacokinetics Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.2.1 Method of Analysis Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.2.2 Absorption Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.2.3 Distribution Provided/ Prepared / Compile / Drafted by MYDossier.in
MYdossier.in Dossier Consultancy Divis ion, Zodiac Pharma
Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, (On Sate Highway No 219)
Madanapalle -517 325, Andhra Pradesh India
Website:- http://www.mydossier.in; Email:- [email protected]
4.2.2.4 Metabolism Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.2.5 Excretion Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.2.6 Pharmacokinetic Drug Interactions (nonclinical)
Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.2.7 Other Pharmacokinetic Studies Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.3 Toxicology Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.3.1 Single-Dose Toxicity Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.3.2 Repeat-Dose Toxicity Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.3.3 Genotoxicity Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.3.4 Carcinogenicity Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.3.5 Reproductive and Development Toxicity Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.3.6 Local Tolerance Provided/ Prepared / Compile / Drafted by MYDossier.in
4.2.3.7 Other Toxicity Studies Provided/ Prepared / Compile / Drafted by MYDossier.in
MODULE 5 CLINICAL STUDY REPORTS Provided/ Prepared / Compile / Drafted by MYDossier.in
5.1 TABLE OF CONTENTS Provided/ Prepared / Compile / Drafted by MYDossier.in
5.2 Listing of All Clinical Studies Provided/ Prepared / Compile / Drafted by MYDossier.in
5.3 Clinical Study Reports Provided/ Prepared / Compile / Drafted by MYDossier.in
5.3.1 Biopharmaceutics Reports Provided/ Prepared / Compile / Drafted by MYDossier.in
5.3.1.1 Bioavailability Study Reports Provided/ Prepared / Compile / Drafted by MYDossier.in
5.3.1.2 Bioequivalence Study Reports Provided/ Prepared / Compile / Drafted by MYDossier.in
5.3.1.3 In-vivo/In-vitro Correlation Studies Provided/ Prepared / Compile / Drafted by MYDossier.in
MYdossier.in Dossier Consultancy Divis ion, Zodiac Pharma
Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, (On Sate Highway No 219)
Madanapalle -517 325, Andhra Pradesh India
Website:- http://www.mydossier.in; Email:- [email protected]
5.3.1.4 Analytical Method Used in Bioavailability
Study
Provided/ Prepared / Compile / Drafted by MYDossier.in
5.3.2 Studies Pertinent to Pharmacokinetics using Human
Biomaterials
Provided/ Prepared / Compile / Drafted by MYDossier.in
5.3.3 Human Pharmacokinetics Provided/ Prepared / Compile / Drafted by MYDossier.in
5.3.4 Human Pharmacodynamics Provided/ Prepared / Compile / Drafted by MYDossier.in
5.3.5 Clinical Efficacy and Safety Studies Provided/ Prepared / Compile / Drafted by MYDossier.in
Thanking you
MYdossier.in Dossier Consultancy Division,
Zodiac Pharma
Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli,
(On Sate Highway No 219) Madanapalle -517 325,
Andhra Pradesh India
Website:- http://www.mydossier.in
To get more information (quote or inquiry) – Direct contact to Mr. Tara chand Tak
CALL, SMS or Whatsapp to +91-965-22-81-81-4 'OR' Email:- [email protected]
MYdossier.in Dossier Consultancy Divis ion, Zodiac Pharma
Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, (On Sate Highway No 219)
Madanapalle -517 325, Andhra Pradesh India
Website:- http://www.mydossier.in; Email:- [email protected]
MYdossier.in Dossier Consultancy Divis ion, Zodiac Pharma
Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, (On Sate Highway No 219)
Madanapalle -517 325, Andhra Pradesh India
Website:- http://www.mydossier.in; Email:- [email protected]
In Sept 2016 - Mr. Tara chand Tak, Founder & CEO of MYdossier attended seminar as SPEAKER. He has share his expertise
on topic "Healthcare product registration strategy for Cambodia - Challenges and Opportunity"
MYdossier.in Dossier Consultancy Divis ion, Zodiac Pharma
Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, (On Sate Highway No 219)
Madanapalle -517 325, Andhra Pradesh India
Website:- http://www.mydossier.in; Email:- [email protected]
In Sept 2016 - In association with VEAS, Vietnam and Cambodia Phar-Med Expo 2016 , MYdossier / Mr. Tara chand Tak
provided free consultancy services to Exhibitors and Visitors.
MYdossier.in Dossier Consultancy Divis ion, Zodiac Pharma
Plot No. 63, 76 & 77, Industrial Park (APIIC) Valasapalli, (On Sate Highway No 219)
Madanapalle -517 325, Andhra Pradesh India
Website:- http://www.mydossier.in; Email:- [email protected]
July 2016 - Mr. Tara chand Tak visited Yangon as Speaker (for event Pharma Med 2016, Myanmar) to share his expertise on
Export management in ASEAN countries.
