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

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