Document and Records Management for Regulatory Submissions

This contract involves providing document and records management services specifically for regulatory submissions to the FDA, focusing on organizing, cataloging, and maintaining electronic records in accordance with FDA records management policies. Key responsibilities include applying metadata tagging and implementing version control to ensure the accuracy, traceability, and compliance of all regulatory documents handled under this agreement. The contract is designated as a subcontract under the NAICS code 561410, which covers office administrative services. The work will be performed primarily in Silver Spring and is managed by the FDA Office of Acquisition and Grant Services within the Department of Health and Human Services. Although no specific solicitation number or set-aside type is listed, the contract is critical for ensuring regulatory compliance and proper document control in support of FDA regulatory submissions. The contract posting date is May 19, 2026, signifying a future engagement aimed at maintaining rigorous standards in regulatory recordkeeping for the agency.