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

Feb 9, 2023

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.



We are well-equipped to provide regulatory advice, discuss strategy and/or compile the registration dossier. 


We have a team of highly qualified pharmacovigilance employees with expertise in all aspects of pharmacovigilance.


We offer high quality medical & pharmaceutical translations into and from several European languages.

Electronic submission

We are equipped to assist with any type of electronic submission and maintenance of your electronic file.

Special medicines areas

Herbal medicinal products, strong vitamin and mineral products, medicinal gasses, euphoriant substances, etc.

GDP & GMP Services

We offer full time and part time responsible person (RP) function and qualified person (QP) function.