FDA-Compliant Labeling of Clinical-Grade Investigational Drugs

The contract requires in-house labeling of investigational drug containers with precise batch numbers, expiration dates, and usage instructions that fully comply with FDA regulations to eliminate the risk of re-shipping nonconforming or mislabeled products. This work must be performed in a controlled environment to ensure accuracy, traceability, and adherence to clinical-grade standards, with all labeling processes rigorously documented to meet audit and regulatory expectations. The opportunity is a total small business set-aside under SBA guidelines, classified under NAICS code 325412 for pharmaceutical preparation manufacturing, and is issued by the National Institutes of Health through the Department of Health and Human Services. Performance is designated for Frederick, Maryland, with a response deadline of July 11, 2026, and is structured as a subcontract, indicating the selected vendor will support an existing clinical or research program under a larger federal initiative.