Mr. Radadiya is responsible for developing and implementing regulatory strategies for new products in development and Saptalis products on the market.
Partha has the expertise as Regulatory Lead in various areas including filing PIND, IND, NDA and ANDAs, APRs, supervising pharmacovigilance activities, managing post-approval changes to products in market and coordinating PAI and GMP inspections. He provides regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, and contingencies. Prior to joining Saptalis, Partha was instrumental in managing Regulatory Affairs at Tedor Pharmaceuticals and Akorn Inc.
Mr. Radadiya holds an M.S. degree in Regulatory Affairs from Northeastern University, Boston, and a Bachelor's degree in Pharmacy from JSS College of Pharmacy, Mysore.
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