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.