Capabilities

Our experienced dossier development team helps you to accelerate your drug development process.

Based in Gent, Belgium, our 25-strong team are experts in writing and formatting supporting documentation, whether it is a scientific report, a quality document or a regulatory dossier.

For more than 25 years, we have focused on Chemistry, Manufacturing & Control (CMC) subjects, hence we can offer you in-depth knowledge, insight and unparalleled experience.

We tailor our service to your needs:

  • We can offer temporary help or long-term support and be your right hand in regulatory affairs
  • We can take full ownership of the documentation in your R&D project (from raw data to regulatory dossier) or bring specific project support
  • Our writers can be integrated into your CMC team or work independently

We have hands on experience with numerous electronic common technical document (eCTD) system providers and can easily adapt to working with sponsors’ software. We also have our own eCTD software.

Our expertise covers:

  • Small/large molecules
  • EMEA/FDA
  • All phases of product development (clinical trial applications, marketing authorisation, variations and dossier maintenance)