Custom Multi-Component Veterinary Drug Reference Standards (Macrolides)

The contract involves the production of ISO 17034-certified reference standards for macrolide antibiotics, specifically including Virginiamycin M1, to be delivered in two certified lots designated as ICV and CCV. Each lot will consist of five 1mL glass ampules, prepared under strict quality control to ensure purity, stability, and consistency suitable for use in LC-MS method calibration within veterinary drug testing. Full traceability of materials, processes, and analytical data is required, with each ampule accompanied by a detailed Certificate of Analysis that verifies identity, concentration, homogeneity, and stability under specified conditions. The standards must comply with international metrological requirements to support reliable analytical results in regulatory and diagnostic labs. The work is solicited as a subcontract under the Department of Health and Human Services, specifically managed by the FDA Office of Acquisition and Grant Services, with performance based in Denver, Colorado, 80225. The solicitation was posted on August 4, 2026, and responses are due by August 7, 2026, indicating a tight turnaround for technical proposal submission. The NAICS code 325412 classifies this as pharmaceutical and medicine manufacturing, underscoring the need for specialized expertise in reference material production. Deliverables must meet the highest regulatory benchmarks for certification, ensuring that the reference materials are fit for use in compliance testing, quality assurance, and method validation across veterinary drug monitoring programs.