From Document to Dossier

(e)CTA? eIND? IMPD? eCTD for new NDA/BLA/MAA? for variation/extension/supplement?

We make sure you're submission ready! We write, review, hyperlink, QC, compile and submit in line with regulatory guidelines.

  • Writing and Review

    • Module 1; region specifics, product information

    • CMC/Quality (M2.3 QOS, M3)

    • Preclinical (M2.4, M2.6 tabulated and written, M4)

    • Clinical (M2.5 overview, M2.7 summaries, M5)

  • eCTD ready documents

    • CTD module templates

    • Word/PDF best practices¬†

    • TOC's, hyper- and crosslinking

  • Quality Control

    • Technical review, QC review

    • Regulatory requirement compliance

    • Validation

    • Time line management

  • Compilation

    • PDF publishing, bookmarking, hyper- and crosslinking

    • Regional/national requirements

    • BLA/NDA/MAA, eIND, CTA, variations, extensions, supplements

    • Dossier life cycle management sequences

  • Submission

    • Global, international gateways (CESP, FDA and national)

    • Simultaneous/parallel, submission strategy

    • Pre-submission meetings

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