Products

US Food and Drug Administration

• 

  CDER and CBER

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  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)