About Sofus


We believe that reliable regulatory expertise is the key to successful market access for your pharma project. The same expertise is required for the effective life-cycle management of your product portfolio.

No matter where you are in the process, we know what regulatory challenges lie ahead. Thanks to our experience, expertise and dedication, we can help you stay one step ahead in your project planning and development, easing your way towards successful market access.


Sofus has specialized in regulatory affairs in pharmaceuticals since 2002.

Be it Development Services or Post-Approval Services, we supply comprehensive regulatory, quality and safety solutions.

No matter whether you’re a multinational corporation or a small business – we can help you shorten the time and distance between your product and the patient.

Sofus was founded in 2002 and currently employ around 60 highly qualified regulatory, quality and safety professionals. We are members of the trade association for the research-based pharmaceutical industry in Sweden (LIF) www.lif.se and Sweden BIO www.swedenbio.se

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