New Drug Application (NDA1, NDA2, NDA3), Full or Abridged route New Drug Application (NDA1, NDA2, NDA3), Verification route Generic Drug Application (GDA1, GDA2), Abridged route Generic Drug Application (GDA1, GDA2), Verification route Major Variation-1, Full or Abridged route Major Variation-1, Verification route Major Variation-2, Abridged route Minor Variation-1, Clinical PI Changes Minor Variation-1, Clinical PI Changes, Verification route Minor Variation-1, CMC Changes Minor Variation-1, CMC Changes, Verification route Minor Variation-2, Notification Minor Variation-2, Do-and-Tell Pharmacovigilance - Updates to Educational/Risk Management Plan Materials Pharmacovigilance - Periodic Benefit-Risk Evaluation Report/Risk Management Plan Reports Submissions to Fulfil Registration Conditions (Non-PV Related) Submission of new, updated Drug Master File, Letter of Access Baseline Submission Submission to Update Change of Registrant (Transfer) in eCTD Other Regulatory Activities