This Government Contract opportunity from Department Of Health And Human Services was posted on April 28, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
Regulatory Support & IND Application Compilation
Contract Overview
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AI Contract Overview
The contract involves the compilation and submission of Investigational New Drug (IND) applications to the FDA, with specific responsibility for authoring the chemistry, manufacturing, and controls (CMC), pharmacology, and toxicology sections. This subcontract is issued under the National Institutes of Health, National Institute of Child Health and Human Development, part of the Department of Health and Human Services, and is classified under NAICS code 541618 for other scientific and technical consulting services. The work requires deep regulatory expertise to ensure all IND components meet current FDA standards and are structured for successful review and approval. The opportunity was posted on April 28, 2026, with a response deadline of May 28, 2026, at 8:00 PM Eastern Time, indicating a one-month window for proposal submission. The place of performance and contact details are unspecified, suggesting the work may be performed remotely or at the contractor's location, with deliverables focused solely on regulatory documentation rather than clinical or laboratory execution.
General Info
Agency
NAICS
Place of Performance
MDSet-Aside
Documents
This scope was carved out of 75N94026R00005.
The full solicitation package (8 documents), including the RFP, is on the prime solicitation, not on this scope.
A--Biological Testing Facility
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Timeline
Submission Closed
Organization & Contact Information
Full Description
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