This Government Contract opportunity from Department Of Defense was posted on June 1, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
Regulatory Strategy and Data Qualification Support
Contract Overview
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AI Contract Overview
The contract involves providing regulatory consulting services to facilitate the FDA qualification process for New Approach Methodologies (NAMs). The focus is on ensuring that the data supporting these NAMs meet stringent regulatory standards, including compliance with Good Laboratory Practice (GLP) and 21 CFR Part 11 requirements. This support aims to validate these alternative testing methods for use in place of traditional animal testing, promoting innovative approaches in regulatory assessments. Issued as a subcontract by the Department of Defense under NAICS code 541611, the contract titled "Regulatory Strategy and Data Qualification Support" was posted on June 1, 2026, with a response deadline of June 12, 2026. The contract underscores the importance of regulatory strategy and data integrity to comply with federal guidelines, although specific details such as location and points of contact are not provided. This opportunity targets organizations capable of navigating complex regulatory frameworks to advance safer and more efficient testing methodologies.
General Info
Agency
NAICS
Place of Performance
MDSet-Aside
Documents
This scope was carved out of W911SR-26-9-NAMS.
The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.
Request for Project Proposals: New Approach Methodologies (NAMs)
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Timeline
Submission Closed
Organization & Contact Information
Full Description
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