eCTD - Publishing

RegInfo could help you in the following categories:

  • Creating eCTD baseline

  • 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 vNeeS

  • 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