Nikhil Mervana

Experience

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  Veeda Clinical Research Limited

  Jul 2014 - Nov 2014

  Research Associate
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  Hester Biosciences Limited

  Dec 2014 - Nov 2015

  Regulatory Affairs

  • Preparation of Dossiers as per CTD & ACTD format, More preferance will be given to ASEAN, Africa, CIS Marketing.• Exposure To Regulatory requirements of CIS and Regulated market• Interpretation & compilation of data for Dossiers.• Co-ordination with Factories/R&D for documents & Samples, Art work preparation. • Exposure to New Product Development.

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  Finar by Actylis

  Dec 2015 - Aug 2016

  Regulatory Affairs Officer

  • Preparation and Review of Drug Master File and Active Substance Master File. • Review of supporting documents required for DMF & ASMF. • Handling of queries received from Regulatory Authorities. • Coordination with different departments (Research & Development, Quality Assurance, Production, Quality Control and Marketing Department) for technical documents required for New Applications DMF and ASMF. • Preparation and review of Site Master File as per Annexure 14 of WHO TRS No. 961. • Applications for New Product Registration Show less

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  Claris Limited

  Sept 2016 - now

  Junior Executive - International Regulatory Affairs (Regulated Market)