Regulatory Review Support

The contract titled Regulatory Review Support is positioned to provide targeted orientation and instruction to regulatory reviewers within the Center for Drug Evaluation and Research at the Food and Drug Administration. The primary purpose is to equip these reviewers with the necessary knowledge and proficiency to effectively utilize specialized, customized tools, systems, and services that have been jointly developed with review offices to enhance and streamline the regulatory review process. This support is designed to ensure seamless integration of technology and process improvements into daily workflows, thereby increasing efficiency and consistency in drug evaluation activities. The solicitation is forecasted under NAICS code 541990, indicating it falls under Other Scientific and Technical Consulting Services, and is managed by the FDA with no set-aside provisions specified. The point of contact for program inquiries is the CDER Acquisition Liaison, reachable at cderacquisitions@fda.hhs.gov, while the contracting officer position remains listed as to be determined. The contract’s place of performance and specific location details are not provided, and the opportunity was posted on May 25, 2026, with further information accessible via the FDA’s official procurement portal.