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Rakhi Shah, PhD

Branch Chief, Division of Pharmaceutical Manufacturing Assessment I, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER

Dr. Rakhi B. Shah is working as a branch chief in Office of Pharmaceutical Manufacturing Assessment (OPMA)/OPQ. Her primary responsibilities include leading the branch on manufacturing process and facility evaluations. She has been in FDA for over 17 years in increasing responsibilities from research scientist, reviewer, team leader and has experience on assessing both new and generic drug applications, supplements, DMF reviews, pre-, post-approval and surveillance inspections. She received her Ph.D. in Pharmaceutical Sciences from Texas Tech University. She has also earned M.S. in Bioprocess Tech and B.S. in Pharmaceutical Sciences from Institute of Chemical Technology, Mumbai Univ, India.

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