REGULATORY AFFAIRS OF HUMAN AND VETERINARY MEDICINES

Medfiles offers comprehensive regulatory services in the Nordic and Baltic countries, and through our regulatory network in more than an additional 90 countries throughout the world. We have a large team of professionals with academic education combined with vast 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 lifecycle of your products.

Marketing authorisation applications

Medfiles’ highly educated team has in average over 12 years of experience of regulatory work, both in the pharmaceutical industry and from an authority perspective.

Maintenance of marketing authorisations

Our experienced maintenance team offers comprehensive product maintenance services for human and veterinary medicines, and herbal medical products regardless of the active substance.

CMC expert services

Medfiles offers a diverse range of expertise for your pharmaceutical chemical documentation needs.

eSubmission

With more than 10 years of experience of eCTD and other eSubmission formats, we are a reliable and experienced partner in eSubmission services.

Product information texts

Our product information team includes both several translators as well as regulatory experts.

Review of promotional material

Our experienced promotional material review team can ensure that all your materials fulfil local requirements.

GDP, Responsible pharmacist and product complaints

Medfiles offers you services of Responsible Person for Wholesale in Finland.

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