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.
Book your free consultation now
or contact us at: info@fgk-rs.com
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 in setting up 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.
