Botanical Drug Safety and Quality Evaluation
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The contract involves conducting comprehensive analytical and preclinical studies to evaluate the safety, composition, and quality control of botanical drug products. This includes performing toxicology screenings and employing standardization methods to ensure the botanical drugs meet established safety and quality standards. The work is focused on supporting regulatory compliance and scientific validation of these products. Awarded by the FDA Office of Acquisitions and Grants Services under the Department of Health and Human Services, this subcontract falls under the NAICS code 541990, which pertains to specialized scientific services. The principal place of performance is located in Silver Spring, with the contract posted on January 13, 2026. The scope and nature of the contract emphasize the critical role of rigorous quality assessment for botanical drugs, contributing to public health protection and regulatory oversight.
General Info
Agency
NAICS
Place of Performance
Silver Spring, MD, 20993, USASet-Aside
Documents
This scope was carved out of FDABAA-25-00123_Award.
The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.
FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
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