Rare Disease Regulatory Operations Support Consultant
The NIH Office of the Director is conducting a market survey to identify qualified small businesses, including 8(a), women-owned, service-disabled veteran-owned, and HUBZone firms, capable of providing International Orphan Drug Designation sponsor/representation and European Medicines Agency regulatory consulting services. Interested firms must submit a detailed capability statement demonstrating relevant experience and technical ability, along with contact information for an authorized point of contact. Responses must identify the firm’s size and business type, and the procurement falls under NAICS code 541690 with a $19 million size standard. This is for market research and planning purposes only, and does not commit the government to a procurement.