Requirements Analysis and Regulatory Workflow Consulting

The contract entails gathering and analyzing business requirements from FDA CTP reviewers to understand their operational needs, mapping existing regulatory workflows, and translating those into detailed technical specifications for enhancements to the Rhapsody platform. This work requires deep familiarity with FDA regulatory processes and the ability to bridge the gap between clinical and compliance workflows and software development, ensuring that system updates align precisely with regulatory expectations and internal review procedures. The contractor will serve as a critical liaison between domain experts and technical teams, contributing to the continuous improvement of systems used in federal tobacco product review operations. Performance of this subcontract is primarily located in Rockville, Maryland, with a NAICS code of 541611 indicating management, scientific, and technical consulting services. The contract is awarded under the Omas Strategic Buying Center - Information Technology, managed by the Department of Health and Human Services, and is positioned to support ongoing modernization efforts within the FDA’s Center for Tobacco Products. Although no set-aside details or point of contact are provided, the posting date indicates the opportunity was made available in May 2026, suggesting a forward-looking procurement aimed at enhancing institutional capacity with specialized regulatory technology expertise.