This Government Contract opportunity from Department Of Defense was posted on April 28, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
Quality Assurance and Compliance Systems Development
Contract Overview
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The contract requires the establishment and ongoing maintenance of a fully FDA-compliant quality management system aligned with 21 CFR Part 1271 and current good manufacturing practices, ensuring rigorous adherence to regulatory standards for biological products. This includes developing and implementing standard operating procedures, conducting internal and external audits, and maintaining a DCAA-compliant cost accounting system to ensure accurate financial tracking and reporting. All activities must support the integrity of the quality system and facilitate continuous compliance in a highly regulated environment. The work is being performed under a subcontract tied to the Department of Defense, specifically through the Army Medical Resources Acquisition Activity, with the primary place of performance located in Frederick, Maryland, zip code 21702. The solicitation was posted on April 28, 2026, and responses are due by May 4, 2026, by 7:00 PM. The NAICS code 541618 indicates the scope relates to other scientific and technical consulting services, underscoring the specialized nature of the quality assurance and compliance support required. The effort demands technical expertise in federal regulatory frameworks, robust documentation practices, and precise financial controls to meet both FDA and defense contracting obligations.
General Info
Agency
NAICS
Place of Performance
Frederick, MD, 21702, USASet-Aside
Documents
This scope was carved out of HT9427-26-RFI-705.
The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.
Cryopreserved Platelets (CPP) for US FDA Licensure
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Timeline
Submission Closed
Organization & Contact Information
Full Description
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