- Drug Master File (DMF)/ Active substance Master File (ASMF) for the domestic and global industries.
- USDMF: United States Drug Master File, (Open and closed part).
- Certificate of Suitability (CEP-COS) of EDQM.
- eCTD Compilation.
- DMF-Life cycle management.
- Technical Packages for Pharma Intermediates.
- DMF review as per ICH guidance.
- Analytical Method Validation and Development for API (Active Pharmaceutical Ingredients) and Pharma Intermediate.
- Elemental analysis for API and impurities.
- Toxicological Evaluation for Pharma Intermediate and API.
- Structure Elucidation of API.
- Quality compliances services for API and Pharma Intermediates.
- Process Validation report for API and Pharma Intermediates.
- Standard Operating Procedures (SOP) drafting for API and Pharma Intermediates.
- Patent: Prior Art search for Pharma Intermediate and API.
- Patentability analysis for Pharma Intermediate and API.
- Freedom to operate (FTO) report preparation for Pharma Intermediate and API.
- Chemdraw expert.•
- HPLC, (High Performance Liquid Chromatography) and GC (Gas Chromatography) analysis.
- QA, Quality Assurance A related- SOP, Process Validation, and Site master file.
- Nitrosamine impurities evaluation.
- Specification and method of analysis set-up.
- Characterization for API- Mass, NMR (Nuclear Magnetic Resonance), IR, (Infer Red) and UV (Ultra Violet Light).
Undisclosed Company, CEO and Director, Present
- Executing over ten years experience exclusively in Active Pharmaceutical Manufacturing companies as member of REGULATORY AFFAIRS DEPARTMENT in India.
- Responsible for all client companies regulatory compliances services in API and Pharma Intermediates.
- Successfully submitted CEP/COS submission to EDQM for M/s. Cadchem, India.
- Prepared and submit the open part documents for Healthcare ltd., Rutu chemicals, and Horster Biosciences in India.
- Drug Master file (DMF) for Non- regulated /Semi-regulated countries
- CEP/COS (Initial Application/Renewals/Revisions/Query responses)
- U. DMF (National /Decentralized/Centralized Procedures)
- S. DMF (Original submission/Amendments/Annual Reports/Query Response)
- eCTD submission support
- EDQM/EU CESP login Creation
- US Agent nomination
- DMF review as per ICH/US/EU/Korea/Japan guidance
- Life cycle management of DMFs
- Technical Packages for Advance Intermediates
- Analytical Method Validation/Development
- Toxicological Evaluation Support
- Training and Development for Regulatory Affairs
Cadila Healthcare Ltd., Ankleshwar, Gujarat, India, Deputy Manager, 2019 - 2020
- (API)- Handling Team of Regulatory affairs
- Chemist-Regulatory Affairs (API), 2010 - 2013
CTX Lifesciences PVT., LTD., Surat, Gujarat, India, Assistant Manager, 2018 - 2019
- Regulatory Affairs (API)-Handling Team of Regulatory affairs
Intas Pharmaceuticals Limited, Ahmedabad, Gujarat, India, Senior Executive, 2015 - 2018
- Senior Executive-Regulatory Affairs (API).
Unique Pharmaceuticals, Ankleshwar, Gujarat, India, Executive, 2013 - 2015
- Executive-Regulatory Affairs (API).
ZCL Chemicals Limited, Ankleshwar, Gujarat, India, Officer, 2013
- Officer-Regulatory Affairs (API).
Professional Industrial Achievements
- Compilation, review and filing of DMFs for various regulatory authorities under different marketing procedures (CP/DCP/MRP/NA) in Europe, to EDQM, to USFDA, to TPD-Canada and to TGA-Australia in accordance to the filing requirements of Regulatory Authorities and periodic updating of USMFs (Annual Updates) and Canadian DMFs (MF Updates).
- Filing of Amendments to USFDA, to EDQM and ASMF updates to competent authorities with different types of changes e.g., Monograph Revision, Revision for Scale-Up processes along with other changes (starting material vendor change, inclusion of multiple vendors for starting material, change in the manufacturing process of API).
- Review and categorization of changes related to API that has impact on the already submitted ANDA/Dossier (Post Approval Changes).
- Addressed the responses to deficiencies received from various regulatory authorities (EDQM/EU/US/TPD/TGA/ROW etc).
- Successfully responded to queries received from the various customers on Applicant’s Part of DMF.
- Resolved major deficiencies responses (i.e., re-definition of the starting materials, impurities controls, genotoxic concerns, etc.) for specific authorities in the global wide.
- Preparation and submission of Open part/ Technical packages as per customer requirement.
- Knowledge about review of Technology Transfer Document, Product Development Report, Characterization Reports, Batch Manufacturing Records, Process Validation Data, Analytical Method Validation Reports, etc.
- Working knowledge about preparation of Drug Master File as per eCTD (Software provided by Educe Solutions, Pharmaready, etc.,) format/NeeS format and submission using Web-client, CESP and ESG Pathway.
Honors & Publications
- Statistical Package for Social science (SPSS) software training and certification
- Pharmaceutical and various types of software: Acrobat professional, Chem-bio Office, and Chemscketch, etc.
- State Pharmacist of Gujarat, India
Academic and Professional Affiliations
- MBA in Total Quality Management
- Master's in pharmacy
- Investigation into the Mechanism- Anti-epileptic
- MBA Total Quality Management, Pharmaceutical, Sikkim Manipal University East Sikkim, India
- M.S. Pharmacology, A.R. College of Pharmacy, Gujarat, India
- B.S. Pharmaceutical Science, C.U. Shah University, Wadhwan City India