From development to marketing authorisation or 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, food and feed products and cosmetics following European regulatory framework.
We have strong presence in the Nordic countries and the 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 food area we have vast expertise in the labeling issues, novel food and health claim regulation. 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.
Medfiles offers regulatory governance such as:
- Regulatory strategies & GAP analyses
- Pharmaceutical & technical documentation
- Marketing authorisation applications & notifications
- EU & other international submissions
- Medical & regulatory writing
- Pharmacovigilance
- Translations
- Health economics & market access
