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The Author is Head of Regulatory Affairs at Martec USA, LLC (a generic pharmaceutical company) and is responsible for all regulatory related activities. the author was with Sanofi-Aventis and its p...view moreThe Author is Head of Regulatory Affairs at Martec USA, LLC (a generic pharmaceutical company) and is responsible for all regulatory related activities. the author was with Sanofi-Aventis and its predecessor companies for 29 years. First 14 years he was in R&D with specialization in solid dosage form pre-formulation, development, scale-up, and technology transfer to manufacturing. Last 15 years with Sanofi-Aventis and its predecessor companies he was in Regulatory Affairs (Chemistry, Manufacturing, and Controls; CMC). His last position was Director of Regulatory CMC. He has submitted CMC section of several tens of INDs, 25 DMFs, eight NDAs/BLAs, several hundreds of post-approval submissions such Annual reports, supplements, etc.
Dr. Shah has widely spoken on regulatory CMC issues along with FDA nationally and internationally. He has chaired and co-chaired several conferences on regulatory CMC. He created the CMC track of the DIA annual conference and has been co-chair since last four years. He has been a visiting faculty at Tufts Universitys Postgraduate Course in Clinical Pharmacology, Drug Development, and Regulation. Dr. Shah has written four chapters on various aspects of regulatory CMC.view less