Cloud-based management software

The Department of Health and Human Services Food and Drug Administration, specifically the Center for Drug Evaluation and Research, is seeking to procure a six-month pilot license for Guardrail cloud-based management software or an equivalent solution. The Office of Prescription Drug Promotion requires this software to automate the screening of promotional materials using Decision Intelligence and Large Language Model hybrid architecture to analyze approximately 150,000 annual advertisement submissions. The software must flag potential regulatory compliance issues with precision and transparency while providing capabilities for labeling consistency validation, explainable decision-making, high-volume scalability, enhanced security architecture, role-based access control, and on-premise deployment options. The procurement will be evaluated using a lowest price technically acceptable basis, focusing on both technical acceptability and price reasonableness. Responses to this Request for Quote are due by September 25, 2025, with the solicitation posted on September 18, 2025.

This procurement does not include any set-aside designations and is open to all qualified contractors, though Klick Inc.'s Guardrail software is specifically mentioned as the reference solution or equal standard. The contract will be awarded as a Firm Fixed Price arrangement for the six-month pilot period, though specific budget ranges or award values are not disclosed in the available documentation. The software solution must be capable of handling the substantial volume of 150,000 annual advertisement submissions that the FDA processes for regulatory compliance review. Performance will take place within the United States, and the procurement falls under NAICS code 541519 for Other Computer Related Services and PSC code 7A20 for IT and Telecom Application Development Software with perpetual license classification.