Project Management and Principal Investigator Oversight

The contract requires the provision of a Principal Investigator and at least one full-time PhD-level researcher to oversee the technical execution of a project involving regulatory compliance and direct interaction with the FDA. The Principal Investigator will lead all technical efforts, ensure adherence to regulatory standards, and serve as the primary liaison between the project team and the FDA to facilitate guidance, submissions, and approval processes. The PhD-level researcher must be dedicated full-time to support the technical and compliance aspects of the project, working in close coordination with the Principal Investigator to deliver results aligned with federal requirements. This is a subcontract under a Total Small Business Set-Aside, classified under NAICS code 541690, and is open only to small businesses as defined by the SBA. The solicitation was posted on July 7, 2026, with a response deadline of July 20, 2026, and is managed by the FDA Office of Acquisitions and Grants Services under the Department of Health and Human Services. The place of performance and point of contact details are unspecified, but work is expected to involve direct engagement with FDA entities, necessitating proximity or coordination capabilities with federal regulatory operations. All deliverables must meet the technical and compliance expectations set by the FDA, and the awardee must demonstrate proven experience in navigating the regulatory landscape for health-related projects.