We are a truly dedicated team, most of us with many years’ experience from the Danish Medicines Agency or headquarter of global companies in Denmark.

We know exactly what it takes to

  • Prepare CTD module 2 and 3 for applications for human medicines.
  • Prepare part 2 for applications for veterinary medicines.
  • Review and give useful feedback on your regulatory documentation.
  • Prepare responses to authority questions.
  • Transform your local reports/raw data into appropriate documentation.
  • Perform gap analysis and due diligence. And recommend a strategy for how to fill the gaps.
  • Prepare ASMF and CEP application

We can assist you with all of the above and more. We also do submissions in eCTD/VNeeS and manage communication with the authorities.

Do you need help with the Quality documentation (CMC) for your medicinal products?

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