Regulatory Compliance and Quality Assurance

The contract titled Regulatory Compliance and Quality Assurance is a small business set-aside subcontract under NAICS code 541620, issued by the Department of Veterans Affairs through the National Cmop Office. It requires the contractor to provide ongoing support for compliance with FDA, DSCSA, and VA regulatory standards, with a focus on maintaining quality control, conducting internal audits, and ensuring audit readiness. The scope includes robust lot traceability systems and the implementation of corrective and preventive actions to address nonconformities and sustain regulatory adherence across all operations. Performance is to be conducted at a location in Shawnee, Kansas with a zip code of 66227, and responses are due by May 11, 2026. The contract is designed to support federal healthcare supply chain integrity and regulatory compliance, demanding a thorough understanding of pharmaceutical and medical device regulatory frameworks. This subcontract emphasizes continuous monitoring and proactive quality assurance measures to mitigate risk and maintain alignment with federal mandates, requiring skilled personnel experienced in FDA and DSCSA requirements, as well as VA-specific protocols for product safety and traceability.