• 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?

Meet with Zwiers! This email address is being protected from spambots. You need JavaScript enabled to view it.

Zwiers Regulatory Consultancy | Pivot Park | Henry Chesbrough building | Kloosterstraat 9 | 5349 AB Oss | The Netherlands
Zwiers Regulatory Consultancy | Matrix V |Science park 406 | 1098 XH Amsterdam | The Netherlands

Tel +31 (0)6 10489150 | info@az-regulatory.com