Regulatory Compliance and REMS Program Management

The contract focuses on the ongoing management of Risk Evaluation and Mitigation Strategies (REMS) program requirements, encompassing critical tasks such as patient registry support, tracking of pharmacy certifications, reporting of adverse events, and ensuring readiness for FDA audits. The objective is to maintain regulatory compliance through continuous oversight and support services that enable the organization to meet stringent FDA requirements effectively. This work involves careful monitoring and management of multiple components to safeguard patient safety and uphold industry standards. Issued by the Department of Veterans Affairs through the 242-NETWORK Contract Office 02, this subcontract opportunity is aligned with NAICS code 541618, which pertains to management consulting services. The solicitation was posted on May 5, 2026, with responses due by May 19, 2026. While specific location details and set-aside information were not provided, the contract underscores the importance of specialized expertise in regulatory affairs and risk management to support the Department's compliance initiatives related to REMS programs.