Since many years we have established ourselves as a reliable partner for regulatory affairs for the local markets in the Nordic region: Denmark, Finland, Norway and Sweden. We provide hands-on services covering regulatory intelligence, procedure coordination and management for filing new applications (DCP, MRP, national), variations, renewals and regulatory launch plans.
All-inclusive life cycle management
We manage the life cycle of your product and make sure you can maintain it on the Nordic market. This of course include translations and the production of information texts such as the SmPC and PIL, including readability testing, labelling and artwork. For instance, it is not always easy to produce a Pan-Nordic-pack!
We are used to handle contacts with the local agencies (DKMA, FIMEA, NOMA and MPA) and also to manage all the relevant catalogue texts in the region, e.g. Pharmaca Fennica, Felleskatalogen and FASS.
We know the pitfalls – and how to avoid them
Our dedicated team will give you expert advice on how to register, launch and maintain your registrations in the Nordics. We know the ‘do’s’ and ‘don’ts’ and are used to work with both NDAs in electronic format and old local dossiers. We can assist you from our office or yours, via contract staffing.
Partner. Director Maintenance Regulatory Services
Phone: +46 8 5600 2003