Regulatory

Documents for international authorities

Our team has the knowledge and experience from different markets around the world so that they can get you exactly what you need.
We provide Drug Master Files (EU and USA), the CMC section of NDA’s, Certificates of Suitability (CEP), Investigational Medicinal Product Dossiers (IMPD’s) and other regulatory documents required in different markets.

We hold ourselves a number of DMF’s and CEP’s filed with the FDA and EMEA.