Permanent Resident of USA (Green Card Holder)
鈥aster of Science in Regulatory Affairs from Northeastern University, Boston along with basic (B.S. in Pharmacy) and advanced (M.S. Pharmaceutics) education in pharmaceutical sciences.
鈥ound knowledge of IND, NDA, ANDA, CMC, e-CTD, Labeling and other regulatory pathways by rigorous course work and academic projects.
Academic Projects: -
鈥-CTD preparation and publishing using FDA recent guidelines
Learning outcomes: e-CTD granularity, Headings & Hierarchies, formatting of files, leaf titles, hyperlinking, bookmarking.
鈥DA meetings: Objectives, timelines, and package preparation
Learning outcomes: Type (A, B & C) meetings with practical ...
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