Orphan Drug Designations (ODD)

The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) provide specific incentives to companies who are granted ODD for their product.

 

BlueReg can determine if your product is eligible for orphan drug designation and provide the necessary support for your European Medicines Agency (EMA) / Food and Drug Administration (FDA) application.

 

 

 

Our experts

Associated News

FDA GUIDANCE – COVID-19

BlueReg continues to monitor the changes in the regulatory guidance and we wish to share...

Learn more

How antibody testing can help us fight COVID-19 ?

There is a high demand around the need for antibody testing and the media frenzy...

Learn more

BlueReg continues to expand in the US opening its second North American office in Boston

Cambridge, Massachusetts, USA, December 13 2019, BlueReg, the consulting organization for life sciences companies, is...

Learn more