Requirements Analysis and Regulatory Workflow Consulting

This contract involves gathering and analyzing business requirements from FDA Center for Tobacco Products (CTP) reviewers to support enhancement of the Rhapsody integration engine. The contractor is tasked with mapping regulatory workflows and translating these processes into clear technical specifications to guide system improvements. The work is focused on streamlining and improving regulatory review operations by aligning technological solutions with the needs of FDA reviewers. The subcontract falls under the NAICS code 541611, which pertains to administrative management and general management consulting services, and is issued by the Department of Health and Human Services through the Omas Strategic Buying Center - Information Technology. Performance of the contract is based in Rockville, Maryland, with a posted date of May 13, 2026. This effort is critical to enhancing the FDA's internal IT capabilities as they relate to regulatory process management and data integration.