http://www.cycloneindiagroup.com

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

Leading Pharmaceutical Consultants of India.

Established in 2001 we have achieved a great excellence in the Sector of Pharma Industry...

1 2 3 4 • Cyclone Ayurvedic and Herbal division 5 • Pharma QA….. Leading Pharmaceutical Consultants • Educational and trainings - QERC 6 • Cyclone pharmaceutical consultants • Cyclone India Essences 7 • Cyclone Pharmaceutical Pvt. Ltd. • 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.

www.cyclonepharma.com

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

Regulatory

Prime Services-

1. DMF compilation 2. Dossier compilation 3. ACTD & CTD Dossier 4. CTD for Russia 5. NDA/ANDA 6. Excipient DMF 7. Dossier for Herbal and neutraceutical 8. Variance Filling Supportive Services – BA/BE study, Clinical trials, Pharmacovigilance, Pharmacological services, Analyical Services, Stability Services Formulation

Prime services-

1. New formulation development 2. Established database of about 10000 different formulations 3. Technology Transfer 4. Method Transfer 5. Formula verification

Supportive services-

Process validation, Analytical method validation, Volumetric solution validation, TLC method validatio n

DMF compilation as per country norms for API, Excipient, Colourants and packing materials CTD, 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

Huge database of Formulations and API.

Having well experienced 15 technocrates working with CPPL Dedicated Senior R & D, QA, QC Experts Around 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

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.

www.pharmaqa.org

Pharma 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 .

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

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……….

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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.

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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.

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

We Provide Quality Service We Meet the Time Frames.

To be world’s best pharmaceutical GMP consultants To serve Pharmaceutical Industry with innovative Idea .

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.

Website

: www.cycloneindiagroup.com

www.cyclonepharma.com

www.pharmaqa.org

www.qercindia.com

E–mail :

[email protected]

[email protected]

[email protected]

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

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

Thank you !

Hoping for the best………….