Regulatory Affairs - Local Markets

 

By being updated on the ever-changing regulatory landscape on your local market, you look into the future. You are prepared to take the right actions at the right time. A reliable, local regulatory expertise saves you time and resources, since even small regulatory issues may grow into big problems if not handled properly. Our Swedish regulatory heritage and our Nordic expertise combine to help you stay ahead and identify and act upon new possibilities that may positively influence your business.

 

You don’t have to know the market. We do.

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.

 

Contact Us:

Hanna Edling
Partner. Director Maintenance Regulatory Services
Phone: +46 8 5600 2003
hanna.edling(at)sofus.se