http://www.cycloneindiagroup.com

CYCLONE INDIA GROUP

Index Introduction Our Group Companies Cyclone India Group companies Our mission

Cyclone Pharmaceutical Pvt. Ltd.• Introduction• Our prime services

Cyclone pharmaceutical consultants• Introduction• Our services• Our expertise• Infrastructure• R & D Analytical set up

Pharma QA• Introduction• Our prime services

How we work Team cyclone One stop solution Future vision Summary Visit us Contact us

Introduction

Leading Pharmaceutical Consultants of India.

Established in 2001

we have achieved a great excellence in the Sector of Pharma Industry...

Our Group Companies

Cyclone India Group Companies1 • Cyclone Pharmaceutical Pvt. Ltd.

2 • Cyclone pharmaceutical consultants

3 • Pharma QA….. Leading Pharmaceutical Consultants

4 • Cyclone Ayurvedic and Herbal division

5 • Educational and trainings - QERC

6 • Cyclone India Essences

7 • BR life science

8 • Swaraj services

9 • Social activities- Rudra Foundation

Service for cGMP & DMF.

Continuous Up-gradation of cGMP System.

Mutually beneficial Professional Partnership with the Valued Customers.

Value Addition towards Regulatory understanding and Compliance.

Training via Creative and Innovative ways.

OUR MISION

Leading Pharmaceutical Consultants of India…www.cyclonepharma.com

CYCLONE PHARMACEUTICAL COSULTANCY

INTRODUCTION

Division of CPPLEstablished in 2002Provides complete support for all kinds of regulatory needs

“Cyclone Pharmaceutical Consultants is another name for QUALITY”

OUR SERVICES

Regulatory

Supportive Services – BA/BE study, Clinical trials, Pharmacovigilance, Pharmacological

services, Analyical Services, Stability Services

OUR EXPERTISEDMF compilation as per country norms for API, Excipient, Colourants and packing materialsCTD, ACTD, eCTD and all other country Specific Dossiers and DMF compilation for Pharma Products.Expertise in Compilation of dossier for Philippine, Vietnam, Cambodia, Myanmar and for all Asian Countries.Dossier Compilation for Latin American, South African, Russian, CIS and Other Countries.Dossier Preparation for Nutraceuticals, Ayurvedic Medicines and veterinary Products.Other regulatory services

INFRASTRUCTUREHuge database of Formulations and API.Having well experienced 15 technocrates working with CPPL Dedicated Senior R & D, QA, QC ExpertsAround 5000 Specifications and STP’s are ready with us.Having Experience of compiling more than 2000 Dossiers.Association with expert from each sector of pharma profession

R & D ANALYTICAL SET UP

Tie up with well equipped R &D and analytical laboratories with following support-

1. Development facility for tablet , capsules, liquid and other dosage form

2. Supporting analytical laboratory with HPLC, HPTLC, TLC, GC, IR, Dissolution Mass Spectra assemblies.

Leading Pharmaceutical Consultantswww.pharmaqa.org

PHARMA QA

INRTRODUCTIONPharma QA is established in the year 2010 as a part of Cyclone India Group.

Pharma QA is known as Best GMP Consultant of India. Pharma QA provides most economic & highest quality services for Pharma industry.

Pharma QA has implemented ‘Quality Integration Project and Pharmaceutical Inspection Convention Services’ first time in the world which provides a integrated quality solution for all your quality needs and gives financial, technical and quality relief to small and middle scale Pharma manufacturer. Pharma QA itself acts as your virtual QA department.

OUR PRIME SERVICES

Quality integration project: Virtual QA

department •Complete GMP, regulatory and production management establishment

•Operational cost reduction•Disciplined quality system which can qualify for audit of the the world

•Minimum document and simplified system

•High quality training to staff and worker

•Prompt and timely deliveries of materials with a quality parameters

•GMP documentation services•Audits and QA moitoring•QP (quality pharmacist service

Validation project

•Equipment validation

•Facility validation

•AHU/HVAC validation

•Water system validation

•Utility validation

Audit services

•New plant audit•Contract manufacturing audit

•Regulatory, WHO, MHRA pre-audit

•Internal audit (self inspection)

•Vendor audit•Consignment audit•QA and documentation audit

•Energy audit•API plant quality system audit

•Assistance to overseas client to monitor quality

Training•On the job GMP training

•QA & Quality system training

•Audit Training•Technical Training

•Refresher Training

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We work with harmony with the customers and FDA.

We focus on Current Regulatory Requirements

We assure value additions to the system.

We provide backup as and when required.

We help the customer to meet all the Queries.

To be continued……….

HOW WE WORK………..

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We monitor Regulations and the "Regulators" on a routine basis.

We sort through the Details, Interpret the Events and determine the right course of action for your organization.

We work with you at a level of Mutual Trust and Satisfaction.

Team cyclone build by Expert Technocrats of Indian Pharma Industry having more than 15 years of Quality Experience-

Our consultants........1. Sachin Bhalekar , B. Pharm, MBA

2. Sandip Ghule , B. Pharm, MBA

3. Kumudini Phapale , M.Sc.(Biotechnology)

4. Avanti Rao, M. Pharm. (QA)

5. Rohit Shinde, (R & D Scientist)

6. Dr. Amol Shah, M. Pharm., Ph. D.

TEAM CYCLONE

One stop solution

We provide practical solutions to the Regulatory Problems related to cGMP / Validation / DMF.

We Provide Quality Service

We Meet the Time Frames.

FUTURE VISION

To be world’s best pharmaceutical GMP consultants

To serve Pharmaceutical Industry with innovative Idea.

Summary

CYCLONE INDIA GROUP is a Young, Dynamic company with a clear knowledge of GMP.It has Customer Satisfaction and Customer Retention as key measurable.It has a reputation built on Quality, Reliability, Responsiveness and Timely Services.It delivers cost-effective Services/Solutions in Regulatory, GMP, quality management, audit, training, manufacturing and marketing.

VISIT US

Website: www.cycloneindiagroup.com www.cyclonepharma.com www.pharmaqa.org www.qercindia.com

E–mail : info@cyclonepharma.com info@cycloneindiagroup.com cp@cycloneindiagroup.com

Contact us…….

Mob. : +91–9673000554/9860900565Tel. : +91–20–65296565Mailing Address :

203, Second floor, Anurag Complex, Above Shivaji Bhosle Co Op Bank, Alandi road, Kalas, Pune-411015.

Thank you !

Hoping for the best………….