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

Technical Consultant #2533


Expertise

  • Drug Master File (DMF)/ Active substance Master File (ASMF) for the domestic and global industries.
  • USDMF- United States Drug Master File.
  • 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 and Pharma Intermediate.
  • Elemental Analysis for API.
  • 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.

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
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