Find your legal representative for successful clinical research business.
Work with the No. 1 partner when it comes to sponsor representation in Europe, Switzerland and the UK.
Book your free consultation now
or contact us at: info@fgk-rs.com
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?
You would like to apply for "orphan designation" (ODD) in the EU to receive incentives for developing orphan drugs and notice that ODD must be held by a legal entity based in the EU?
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.
Orphan Medicinal Product Regulation requires that the sponsor seeking to obtain the designation of a medicinal product (=drug) as an orphan medicinal product must be established 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?
- Book a free consultation with our Regulatory Affairs experts.
- Get all the information needed regarding drug or medical device studies for your target market.
- Set up a contract with us to be CT/MD/IVD Regulation compliant.
- 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.
You can rely on us. We are:
focused on the individual need of our customers
flexible & fast
professional regulatory experts, each having 10+ years of experience
Book your free consultation now:
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Angela Denzel
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.
