From Document to Dossier

We make sure you're submission ready! We write, review, hyperlink, QC, compile and submit in line with the official document requirements.

  • eCTD ready documents
  • Compilation and submission
  • Dossier conversions
  • Module writing and review: M1, CMC (M2.3 QOS) preclinical (2.4, 2.6), clinical (M2.5 overview, M2.7 summaries)
  • Policy 0070; redaction, writing (anonymisation, justification) and review

We write, review, hyperlink, QC, compile and submit in line with the official document requirements.

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

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