Regulatory affairs

Regulatory services

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Headshot of Helena Björkman head of Regulatory services in Sweden

We tailor the solutions to meet your needs

We are experts and have a long experience within Regulatory Affairs. We work together to find flexible solutions and help you meet your deadlines, all hands-on deck when required.



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OUR TEAM

Our consultants have a long and broad experience from HQ and affiliates, small pharma companies and global pharma companies, vaccines, biologicals, medical device, cosmetics, food supplements and nutrition. We have Nordic team with local experts in Sweden, Denmark, Norway and Finland.


Our staff is composed of consultants who are carefully selected and recruited by us to fit into the role of consultancy and thereby being able to adapt to various assignments.

PHARMACEUTICALS

We are market leader within Regulatory Affairs in the Nordics. The team has a long and broad experience within pharmaceuticals. From drug development to launches to maintenance.

MEDICAL DEVICES

With our long experience within medical device, from both regulators and manufacturing point of view we can help you with management and expertise within quality assurance, regulatory affairs and general safety and performance. How can we assist in your specific needs?

FOOD SUPPLEMENTS & FOOD

The requirement on food and food supplements differs in the Nordic countries. There are local regulations and EU legislation that you need to consider before placing your product on the specific market. We can help you with this.

COSMETICS​

The cosmetic industry follows the cosmetic regulation and all products needs to be registered in the CPNP. How can we help you?

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