Find your legal representative for successful clinical research business.

Your challenge:

You would like to start a clinical study in Europe, Switzerland or the UK and notice that for a drug study or a MD/IVD study in Europe a so-called “legal representative” is required?

What exactly does this mean for you?

A sponsor company that does not have a subsidiary in the European Union and wants to carry out a clinical study in the EU needs a “legal representative”. This applies to clinical studies with test substances according to the Clinical Trial Regulation (CTR) and/or medical devices according to the Medical Device Regulation (MDR).

In detail: Regulations (EU) 536/2014 for Clinical Drug Trials (CTR), Regulation (EU) 2017/745 for Medical Devices (MDR) and Regulation (EU) 2017/746, the In-Vitro-Diagnostic Medical Device Regulation (IVDR) require that a sponsor who is not based in the EU must appoint a representative if this sponsor wishes to conduct a clinical study in the EU.

Our solution:

Highly experienced regulatory experts will provide you or your contracted local CROs with competent, quick and cost-efficient sponsor representation services within the European Union, Switzerland and the United Kingdom.

How does it work?

1. Book a free consultation with our Regulatory Affairs experts.
2. Get all the information needed regarding drug or medical device studies for your target market.
3. Set up a contract with us to be CT/MD/IVD Regulation compliant.
4. Start your clinical study in Europe.

We may also support you with your submission for an Orphan Drug Designation or in getting a SME status in the EU.

Book your free consultation now

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