Regulatory services

From development to marketing authorisation / registration to product maintenance, Medfiles helps you meet regulatory challenges with proven strategic guidance at every stage of the product lifecycle. Medfiles offers regulatory services for pharmaceuticals, medical devices, IVDs, food and feed products, and cosmetics following European regulatory framework.

We have a strong presence in the Nordic and Baltic countries, and through our permanent regulatory network we cover national procedures in most of European countries and outside Europe. We have expertise in human and veterinary medicinal products, sterile and non-sterile products, and biopharmaceuticals. In the food area, we have vast expertise in labelling issues, novel food, and health claim regulation. We also offer comprehensive expert services covering the entire product lifecycle of medical devices and in vitro diagnostic devices. Our personnel undergo continuous training and keep up with the latest regulatory requirements and practices to ensure that you receive services of the highest quality.

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Medfiles is a member of the regulanet® the Network of Regulatory Affairs consultants with members in 90 countries throughout the world.

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