Dossier development

Smart, dossier-centric drug development.

Pharmaceutical dossier preparation services form an important part of our role in navigating customers through drug development.

Our dossier-centric approach to projects means our customers stay ahead of the game when it comes to advancing products to clinic.

From data review and reporting to regulatory dossier writing and submission, we can help. Our track record speaks for itself…

  • > 500 marketing authorisation dossiers, including variations and extensions
  • > 300 clinical trial applications (IMPDs, INDs)
  • > 50 certificates of suitability (CEPs)
  • > 10 long-term customer projects related to implementation of new legislation and compliance
  • > 100 drug product development reports
  • > 100 API development reports

We work with you to compile your regulatory dossier in parallel with drug development, saving you time, identifying hurdles and fast tracking your product towards compliance.

Our expertise covers:

  • Chemical drug products
  • Biotechnology drug products (vaccines, monoclonal antibodies, peptides, stem cells)
  • Active (bio)pharmaceutical ingredients
  • Excipients
  • Herbal & vitamin/mineral Products
  • Packaging materials
  • Medical devices