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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

Closed
Federal

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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

Development and submission of FDA-compliant SPL XML for two NDA products, Maryland, deadline June 2026.

Agency

Department Of Defense → Army Medical Resources Acq Activity

NAICS

541611 - Administrative Management and General Management Consulting Services View NAICS

Place of Performance

Frederick, MD, 21702, USA

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PhaseClosed
Posted

subcontract

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Defense → Army Medical Resources Acq Activity
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Defense → Army Medical Resources Acq Activity
Office AddressN/A
ContactsNo contact information available

Full Description

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Create, update, and submit electronic Structured Product Labeling (SPL) in XML format for two FDA-regulated NDA products, ensuring compliance with FDA standards and government review requirements.