Priyal Modi

Experience

1. Pharmaceutical Scientist

   FDA

   Nov 2022 — Present · Silver Spring, MD, US

   Primary responsibilities are review and evaluate comprehensive information on chemistry, formulation, manufacturing of pre-marketing ANDA submissions. • Provide recommendations and decisions in areas where precedents and guidelines are inadequate, utilizing scientific background and understanding of broad legislation, policy statements, and regulatory program definitions.• Identify and analyze manufacturing process variables affecting pharmaceutical intermediates and finished products for various manufacturing processes through scientific or engineered approaches.• Evaluate the adequacy of sponsors data and results with including DS/DP manufacturing, in-process, release and stability using appropriate quantitative tools or mathematical approaches.• Participate in facility inspections related to the evaluation of manufacturing processes and controls and in support of pre-approval and continuous good manufacturing practices (cGMP) inspections.

Education

• LIU Brooklyn

  Master's degree, Industrial and Physical Pharmacy and Cosmetic Sciences

  2007 — 2009

• South Gujarat University

  Bachelor of Pharmacy (B.Pharm.), Under Graduate

  2002 — 2006