Both the EU and the US have economic incentives available that promote the development of Orphan Medicines for these rare indications.

These incentives include protocol assistance, market exclusivity and fee reductions.

Our strategic regulatory experts can assist in Orphan Drug Designation applications to the FDA/EMA and can also assist in the maintenance of the designations.

Get in touch
with our Xpert

Elise Destrée

Managing Consultant, Regulatory Affairs