Find your sponsor representative for Orphan Drug Designation.

Work with the No. 1 partner when it comes to sponsor representation in Europe, Switzerland and the UK.

Your challenge:

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?

Our solution:

Highly experienced regulatory experts will provide you or your contracted local CROs with competent, quick and cost-efficient sponsor representation services enabling application for ODD in the EU.

How does it work?

Book a free consultation with our Regulatory Affairs experts.
Get all the information needed regarding orphan drug designation in your target market.
Set up a contract with us to be Orphan Medicinal Product Regulation (EC) No141/2000 compliant.
Benefit from the incentives of orphan drug designation in Europe.

We may also support you with 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.