We can handle the translation of product information to and from English and Danish, Swedish, Norwegian and Finnish, and we can assist you with preparation of mock-ups and advice on Scandinavian guidelines on packaging.
- Translation of product information
- Nordic packages
After the registration is successfully approved, we can take care of your life-cycle management, such as the preparation and submission of variations, PSUR submissions and renewals, and reporting to EudraVigilance.
- Preparation and submission of variations, PSURs and renewals
- Medical expertise for clinical statements
- Reporting to EudraVigilance and the XEVMPD
If you need in-house assistance or a substitute for a Regulatory Affairs Manager or assistant, we can help you. We are also very experienced in acting as an external Regulatory Affairs department for Scandinavian businesses assisted by a network of regulatory affairs consultants in the Scandinavian countries.
- Substitute for Regulatory Affairs Manager or assistant
- In-house assistance
- External Regulatory Affairs department for Scandinavian businesses
For questions or requirements in regards to Regulatory Affairs, please include a few details in our contact form.