Products

US Food and Drug Administration

CDER and CBER

  • Templates for paper and electronic hybrid or eCTD format
    • Investigational New Drug (IND)
    • Drug Master File (DMF)
    • Abbreviated New Drug Application (ANDA)
    • New Drug Application (NDA)
    • Biologics License Application (BLA)

FDA CDRH

  • Templates for paper and Electronic Copy format
  • Investigational Device Exemption (IDE)
  • Premarket submissions
    1. Premarket Notification (510k)
    2. Premarket Approval (PMA)
    3. Master Files (MAFs)

ASEAN

  • Templates for paper and electronic format ACTD

Health Canada

  • Templates for paper Clinical Trial Authorization and Amendments (CTA and CTA-A)
  • Templates for paper or eCTD format for New Drug Submission (NDS)

European Medicines Agency (EMA)

  • Templates for paper, Non-eCTD electronic Submission (NeeS)
    or eCTD format for Marketing Authorisation Application (MAA)
  • eCTD Module 1 for EMA Centralised Procedure
  • eCTD Module 1 for individual National Competent Authorities (NCAs)