• 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

  • 1

From Aim to Action

Zwiers Regulatory Consultancy maintains the product lifecycle. From the very start until way after approval.

  • Legal entity changes
  • Manufacturing changes
  • CTAs/INDs
  • Due diligence
  • Variations, labelling changes
  • post-approval commitments

Coordination is key! Executing regulatory goals and fulfilling requirements can put a large burden on your resources. We reduce this burden by taking over all activities and handling regulatory procedures.

Maximise your product's potential?

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