eCTD - Publishing

RegInfo could help you in the following categories:

  • Creating eCTD baseline for BREXIT and other national procedures
  • Using a validated eCTD publishing tool to compile and publish the eCTD submissions
  • Formatting of Microsoft® Word and Adobe® PDF documents to comply with the ICH’s PDF specifications
  • Creating hyperlinks between the various CTD sections for ease of navigation and review
  • Compile NeeS
  • Conversion from ACTD (for ASEAN countries) to eCTD
  • Consultancy in dossier compilation for: EU, USA

We have extensive experience in publishing the following regulatory documents to the:

  • EMA
    • Centralised procedures - Initial Marketing Authorisation Application (MAA)
    • Variations
    • PSUR submissions
    • Submissions via eSubmission Gateway
  • EDQM
    • ASMF
    • ASMF for CEP
  • European Health Authorities
    • MRP & DCP dossiers and other submissions
    • National dossiers and other submissions
    • Submissions via CESP
  • FDA
    • Original Dossiers:
      • New Drug Application (NDA) Investigational New Drug Application (IND)
      • Biologics License Application (BLA)
    • Supporting Documentation:
      • Protocol amendments
      • Investigator documents
      • Promo materials
      • Expedited pathway submissions
      • Annual Reports
    • DMFs