The Orphan Medicinal Product Regulation (EC) No 141/2000 requires that the sponsor seeking to obtain or having obtained the designation of a medicinal product (=drug) as an orphan medicinal product must be established in the EU.
FGK Representative Service GmbH offers to serve as the formal sponsor in the EU.
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.