Phanideep Avupati

About Phanideep Avupati

Global Regulatory Affairs Strategist with robust industry experience and honing knowledge on Food and Drug Administration (FDA), European Medicines Agency (EMA) and other major HA\'s laws, guidance, and regulations. Thorough understanding on drug development with experience from early-stage through post-approval. • RAPS (RAC-Drugs) Certified Regulatory professional with 11+ years of experience in Solid orals, Injectables, Semi solids dosage forms and complex generics drug applications pre-approval procedures for ANDAs, 505b2, NDAs, NCE -1, FTF molecules and Paragraph-IV applications to US FDA and ANDS, DIN-OSIP to Health Canada. • Managing Post approval changes to US, Canada, EU, Australia, New Zealand and ROW markets for commercial drug products. • Query response handling. • Regulatory change assessment and Strategy development for PAC. • Years of hands on experience with eCTD and submissions including IND/NDA annual reports (DSURs, PSURs), Pediatric Investigational Plans (PIP)/Pediatric Study Plans (PSP), orphan drug designation applications (and annual reports), investigator brochures (IBs), protocol amendments, and authoring cover letters/1571/356h forms. • Extensive experience with multiple technical applications and documents management systems (DMS) including CARA/GDMS, PDM, PEARL (LIQUENT INSIGHT), Rosetta Viewer, SaraDMS, SubPub, docuBridge and Veeva Vault. • I also enjoy mentoring professionals/students of regulatory background.

Experience

1. Regulatory Alliance Manager, Technical Competence Center

   Sandoz

   Sep 2024 — Present · Hyderabad, IN

Education

• Maharajah's College of Pharmacy (affiliated to Andhra University)

  M.Pharmacy

  2012 — 2014