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Index Introduction Our Group Companies Cyclone India Group companies Our mission Cyclone Pharmaceutical Pvt. Ltd. Introduction.

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Presentation on theme: "Index Introduction Our Group Companies Cyclone India Group companies Our mission Cyclone Pharmaceutical Pvt. Ltd. Introduction."— Presentation transcript:

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2 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

3 Leading Pharmaceutical Consultants of India. Established in 2001 we have achieved a great excellence in the Sector of Pharma Industry...

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5 1 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

6 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.

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9 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 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

10 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

11 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

12 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.

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14 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.

15 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

16 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………. 16

17 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. 17

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

19 We provide practical solutions to the Regulatory Problems related to cGMP / Validation / DMF. We Provide Quality Service We Meet the Time Frames.

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

21 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.

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23 Mob. : +91– / Tel. : +91–20– Mailing Address : 203, Second floor, Anurag Complex, Above Shivaji Bhosle Co Op Bank, Alandi road, Kalas, Pune

24 Thank you ! Hoping for the best………….


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