Pharmaceutical API, DMF, ASMF, Filing, Review and Toxicology Evaluation Expert

Expertise

• 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).

Experience

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.

Client Services 

• 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

Credentials

• Statistical Package for Social science (SPSS) software training and certification
• Pharmaceutical and various types of software: Acrobat professional, Chem-bio Office, and Chemscketch, etc.

License

• State Pharmacist of Gujarat, India

Languages

• English
• Hindi
• Gujarati

Academic and Professional Affiliations

• MBA in Total Quality Management
• Master's in pharmacy

Publications 

• Investigation into the Mechanism- Anti-epileptic 

Education

• 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