Regulatory affairs of human and veterinary medicines
Medfiles offers comprehensive regulatory services in the Nordic and the Baltic countries, and through our regulatory network also in more than 90 countries throughout the world. We have a team of professionals with academic education combined with a long work experience in the pharmaceutical industry and regulatory authorities. Whether you are representing big pharma, SME or an academic research organisation, you can outsource any regulatory duties to us along the life cycle of your products.
Marketing authorisation applications
Planning of marketing authorisation strategy
Preparation and management of applications
Evaluation of marketing authorisation dossiers
Coordination of MRP, DCP, NP and CP processes
Acting as applicant and Marketing Authorisation Holder