This Government Contract opportunity from Department Of Defense was posted on May 15, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
Structured Product Labeling (SPL) Development and Submission
Contract Overview
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AI Contract Overview
The contract involves the development, updating, and submission of electronic Structured Product Labeling (SPL) in XML format for two FDA-regulated New Drug Application (NDA) products. The work requires ensuring that all SPL documents comply with FDA standards and meet all government review requirements. This subcontract is issued by the Army Medical Resources Acquisition Activity under the Department of Defense, with the place of performance designated in Frederick, Maryland. Key deadlines include a response deadline of June 5, 2026, following the posting of the contract on May 15, 2026. The contract falls under the NAICS code 541611, which pertains to administrative management and general management consulting services. The primary objective is to ensure that the electronic labeling submissions conform precisely to regulatory standards, facilitating timely FDA approval and compliance, crucial for maintaining the regulated status of the products involved.
General Info
Agency
NAICS
Place of Performance
Frederick, MD, 21702, USASet-Aside
Documents
This scope was carved out of PANDHA-26-P-0000035401.
The full solicitation package (10 documents), including the RFP, is on the prime solicitation, not on this scope.
Structured Product Labeling (SPL) HT9426-26-Q-E022
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Timeline
Submission Closed
Organization & Contact Information
Full Description
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