Prashant Gudhate

Biography

  Prashant holds post graduate degree in Organic Chemistry from Pune University. Prior to joining us, he was associated with Dr. Reddy's Laboratories as Director – CQA, responsible for overall quality function for all API plants of DRL located in India. With over more than 25 years in the pharmaceutical industry, he has acquired expertise in multiple functions - Quality Assurance, Regulatory Affairs, Quality Control, Manufacturing & Basic Research. During his tenure, he has handled various positions with increasing level of responsibilities with       well known Pharma companies like, Sandoz, Aarti Industries, RPG Life Sciences and Hoechst Marion Roussel Ltd. (Aventis). He has excellent exposure for auditing practices followed by regulatory authorities- USFDA, EDQM, TGA, WHO & ISO 9001. Besides post graduate degree, he is also certified by TUV as lead auditor for Quality Management Systems of ISO 9001:2008 At FBL, Prashant is responsible for providing leadership across the organisation, to elevate Quality systems, in order to assure Quality is built- in to Product’s meeting current regulatory as well as customer expectations. His overall experience contributes to formulate regulatory strategies to meet requirements of various regulatory authorities. He oversees and participates in the preparation and filing of regulatory documents with FDA and international regulatory agencies, maintaining successful collaboration with regulatory agency representatives.

Research Interest

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