Head Office Regulatory Affairs

 

Whether your need is within product development, market introduction or maintenance, our dedicated team of experts is ready to take full responsibility for your project’s every need. Our foresight and knowledge of the ever-changing pharmaceutical landscape will make sure you stay one step ahead. Outsourcing your pharma project to Sofus will allow you to remain focused on your core business.

 

The power of outsourcing

Taking regulatory project lead for a product or a portfolio on the international market means that you lead and coordinate the various projects, such as NDAs, variations, line-extensions, MAH-transfers, and PIP-procedures. Also, you are the global contact point for the local markets. This means setting the standards, and in order to be trusted with this role you need many years of experience. Only then do you know how to perform properly and efficiently.

Wherever your project is based

Our consultants have extensive experience from managing product portfolios and leading regulatory projects on the global market, from US or Europe to Asia – and in all stages through development and maintenance. We are used to collaborate both with big pharma as well as small companies with the same dedication and accuracy.

European registration specialists

We can also assist you with specific services for European registration dossiers and we support all European registration procedures, from centralised procedure (CP) to decentralised procedure (DCP) and from mutual recognition procedure (MRP) to national procedures – including referrals. To support our work, we use Extedo’s eCTD-manager. We can also provide you with other services within publishing, such as CESP and management of XEVMPD.

 

Contact a specialist:

rolf_eriksson

Rolf Eriksson
Partner, Director Head Office Regulatory Affairs
Phone: +46 8 5600 2021
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