Service & Products
CMC filing
Service overview:
Biopeptek’s regulatory team offers documentation support for IND and NDA applications globally. Our team has experience preparing Module 2 and Module 3 of your regulatory dossier.
  • Batch record review
  • Document management and control
  • Deviations/Investigations
  • CAPA follow-up and tracking
  • Complaint management
  • Product release
  • Phase appropriate control systems consulting
  • CMC compilation
  • DMF compilation and submission
  • Annual product reviews