Rare Disease Regulatory Operations Support Consultant

Description: The National Institutes of Health (NIH), National Institute of Child Health and Human Development (NICHD), issued this active Sources Sought notice to identify qualified small businesses for international Orphan Drug Designation (ODD) sponsor/representation and European Medicines Agency (EMA) and international regulatory consulting. Interested firms must submit a capability statement showing their experience, skills, and ability to meet the Government's requirements, together with the requested point-of-contact details and applicable descriptive literature, delivery timeframe, warranties, and other information. The notice is a Contract Opportunity rather than a grant, was published as "Aug 12, 2026 08:10 pm EDT," and sets the response deadline as "Aug 19, 2026 10:30 am EDT."