Local expertise in Regulatory Affairs for the Nordics

Nordic Regulatory Affairs expertise

We know the Nordic markets. Whether you are looking for regulatory support to manage a project, a product launch, or cover a role in your organisation – we have the flexibility to meet your needs. We offer compliance and local regulatory intelligence to give you a competitive advantage.


Local regulatory support

Our experienced specialists can take on full responsibility for all your Nordic regulatory affairs activities. This means managing the full regulatory lifecycle in the Nordic markets and handling all local requirements e.g. labelling and product information, authority communication and regulatory intelligence. This can be carried out as part of our Contract Pharma Organisation offering, on project basis or in a specialist consulting solution.  

Database management is provided by specialists with deep understanding of the local requirements, ensuring correct management of FASS, LiiV, Felleskatalogen, Pharmaca Fennica and DKMAnet.

We also offer experienced specialists to project manage production and review of common artworks for all the Nordic markets.

Lifecycle Management

Local expertise to keep your product on the Nordic markets and maximise the value for patients.

Regulatory intelligence

Stay on top of local legislative updates, to keep your strategic decision making compliant and efficient.

Ethical review of promotion materials

Make sure your Nordic promotional materials are compliant as well as competitive.

Local product information services

High quality texts that follow the correct local templates and guidance documents.

Are you considering launching in the Nordics?

With Arex as your Contract Pharma Organisation, your profits are free to grow alongside your product in the new market.

Your contact person

Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.