Definitive Contract 75F40124C00028

This is a labor-hour award made by the U.S. Food and Drug Administration (FDA) to Agisol LLC, an 8(a) certified small disadvantaged business, to provide regulatory review of the Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) production support services for the Center for Drug Evaluation and Research (CDER). The contract, valued at $4,499,636.43, runs from the award date of February 4, 2024 through December 17, 2025. Agisol LLC has extensive experience supporting the FDA's regulatory processes and systems, including work on initiatives within CDER and other FDA centers. The company holds an 8(a) STARS III Government-Wide Acquisition Contract (GWAC) with the General Services Administration (GSA), which has enabled it to secure significant task orders from the FDA for various IT services and solutions related to the agency's mission-critical activities.