Work with the No. 1 partner when it comes to sponsor representation in Europe, Switzerland and the UK.
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.
We may also support you with your submission for an Orphan Drug Designation or in getting a SME status in the EU.
focused on the individual need of our customers
flexible & fast
professional regulatory experts, each heaving 10+ years of experience
Director Representative Affairs
Your successful clinical development is our goal. You can rely on our expertise. The familiarity of FGK`s team in a frequently changing regulatory environment is an excellent basis for a long-term partnership.