Services

We support any type of CMC writing activity at all stages of the drug development process. Our track record of success speaks for itself:

We have completed:

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