Orphan Drug Designation & Management

Orphan drug development has increased significantly over the last decade as technology developments have enabled a new ‘art-of-the-possible’ for the diagnosis, treatment and prevention of rare medical conditions. In part, the growth in this area has been stimulated by generous incentives (7-10 year market exclusivity, protocol assistance, reduced fees, tax credits for clinical trials) which allow product development for these rare conditions/small patient populations.

Peritus Regulatory support:

• Regulatory advice on Orphan Drug Designation for your product
• Manage your Orphan Drug Application with the agencies
• Attend Agency meetings