Regulatory Compliance and Validation Support

The contract seeks consulting services to support compliance with 21 CFR Part 11, focusing on system validation, documentation, and audit readiness for regulated environments. The scope includes developing and implementing IQ, OQ, and PQ protocols, providing audit support, and ensuring all validation activities meet federal regulatory standards. The work is intended to strengthen the integrity and compliance posture of systems used in clinical and research operations under the oversight of the National Institutes of Health. This subcontract is posted under the NAICS code 541611 for management consulting services and is performance-based at the Bethesda, Maryland location with a response deadline of July 21, 2026. The contracting activity is aligned with the Department of Health and Human Services and targets contractors with proven expertise in pharmaceutical and biotech regulatory environments. All deliverables must align with FDA expectations for electronic records and signatures, requiring a technical approach that combines thorough documentation, validated methodologies, and a clear understanding of current regulatory guidance.