Orphan Drugs
Sharp regulatory has experience in Orphan drug submissions in EU and US. In Europe the benefits of orphan designation include 10 years exclusivity when the product is licensed, and the holder is entitled to protocol assistance at reduced costs with the EMA and reduced Marketing Authorization fees. In US the benefits include seven years exclusivity when the product is first approved, waiver of the NDA/BLA fees, and the company may be eligible for 50 percent tax credits for clinical trials if the company has a US base.
Getting in touch
If you would like to have an initial conversation about your requirements please contact Angela ……
Mobile Number: +44 (0)7738 971523
Email: [email protected]