Regulatory Strategy and FDA Submission Support

This contract involves providing regulatory consulting services to ensure that assay development aligns with FDA expectations specifically for developmental neurotoxicity assessment. The scope includes strategic guidance to facilitate compliance with regulatory standards and assistance in preparing future submission documentation required by the FDA. The contract is a subcontract issued by the FDA Office of Acquisition and Grant Services within the Department of Health and Human Services, with performance expected in Silver Spring. The solicitation was posted on May 21, 2026, with a response deadline set for June 12, 2026. The work falls under NAICS code 541611, indicating it pertains to administrative management and general management consulting services. Although specific details such as organization type and set-aside status are not provided, the contract is focused on supporting the FDA’s regulatory framework to streamline the developmental neurotoxicity testing process through expert consultation.