Regulatory Compliance and REMS Program Management

The contract involves the ongoing management of a Risk Evaluation and Mitigation Strategy program to ensure full compliance with FDA requirements, including support for patient registries, tracking pharmacy certifications, and managing adverse event reporting processes. The contractor will be responsible for maintaining audit readiness for FDA inspections, ensuring all documentation, procedures, and systems are fully aligned with regulatory expectations and continuously updated to reflect changing guidelines. This is a subcontract under the Department of Veterans Affairs, specifically managed by the 242-NETWORK Contract Office 02, and is classified under NAICS code 541618 for other scientific and technical consulting services. The solicitation was posted on May 5, 2026, with a response deadline of May 19, 2026, at 8:00 PM Eastern Time. There is no set-aside classification specified, and the place of performance and point of contact details are not provided. The work is critical to sustaining the safe and compliant distribution of regulated pharmaceutical products under the REMS framework and requires expertise in regulatory affairs, data management, and quality assurance systems. Performance will involve close coordination with healthcare providers, pharmacies, and regulatory authorities to uphold the integrity and effectiveness of the REMS program.