Our highly talented Regulatory Affairs team covers the entire life cycle of human and veterinary medicines. Our team consists of well-experienced regulatory affairs specialists with solid language skills. Continuous training ensures that our team’s knowledge of the relevant legislation is up to date.
From individual projects to outsourcing of the marketing authorisation process
- We plan, compile and write marketing authorisation applications for human and veterinary medicines to all Nordic countries
- We maintain marketing authorisations and can help with, for example, variations, renewals, transfer applications and OTC-applications
- We prepare and update product information texts (SmPCs, PLs and labelling) for selected Nordic languages together with our translators
- We assist you with the registration of herbal products and nutritional additives, as well as cosmetic products.
- We perform ethical and medical review of your promotional material
Our experienced Regulatory Affairs experts help you with single projects all the way to handling the entire marketing authorisation.