Orphan Drug Designation

Rare diseases are pathologies that affect less than 5 out of every 10,000 inhabitants in the European Union and less than 200,000 people in the United States.

Both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) offer a series of economic and strategic advantages for companies wishing to develop an orphan drug.

Orphan drug designation can be applied for at any stage of product development, provided that there is sufficient information (empirical and/or bibliographic) to demonstrate that our product could be effective in the treatment of the disease for which we are applying for orphan designation.

If you are developing a drug for the treatment of an orphan disease and you would like us to assist you in applying for orphan drug designation, please contact us without obligation.