Preparation of Regulatory Submissions

PharmaLex works with their clients to prepare all regulatory documents required for applications. Our extensive understanding of FDA, EMEA and ROW requirements ensures submission of clear and reviewable documents that regulatory agencies can trust.

  • US Drug Master File (DMF)
  • European DMF (EDMF)
  • IND (US)
  • IMPDs/CTAs (EU)
  • New Drug Application (NDA): 505 (b)(1), 505 (b)(2), 505 (j)
  • Biological License Application (BLA)
  • Supplemental New Drug Application (sNDA)
  • EU Market Authorization: Centralized Procedure, Mutual Recognition,  Decentralized Procedure
  • Full electronic Common Technical Document (eCTD) capabilities for global submissions
  • Maintenance documents (e.g., annual and informational updates)