Dr. Nagami has 30+ years of experience in preparing, reviewing, and managing documents and regulatory application submissions that support sponsor and investigator INDs, CTXs, CTAs, Orphan Drug Applications, REMS, SPA, NDAs, MAAs, eCTDs, and DMFs.

She also has extensive experience in coordinating, managing, and conducting regulatory meetings (pre-IND, end-of-phase 2, pre-NDA, CMC, Special Protocol Assessments, etc.) between Sponsors and Regulatory Agencies. She is responsible for regulatory review and approval of company documents, including SOPs, product specifications and methods, protocols, study reports, press releases, etc.