Reports and Submissions

(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
  • eCTD ready documents
  • Quality Control
  • Compilation
  • Submission
  • 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)
  • CTD module templates
  • Word/PDF best practices
  • TOC’s, hyper- and crosslinking
  • Technical review, QC review
  • Regulatory requirement compliance
  • Validation
  • Time line management
  • PDF publishing, bookmarking, hyper- and crosslinking
  • Regional/national requirements
  • BLA/NDA/MAA, eIND, CTA, variations, extensions, supplements
  • Dossier life cycle management sequences
  • Global, international gateways (CESP, FDA and national)
  • Simultaneous/parallel, submission strategy
  • Pre-submission meetings
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Zwiers Regulatory Consultancy is a ProductLifeGroup Company

ProductLife Group’s mission is to improve human health by delivering regulatory & compliance services for the safe and effective use of medical solutions. PLG supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 150 countries.

Product LIfe Group