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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

Closed
Federal

Contract Overview

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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

Provide regulatory consulting to support FDA qualification of NAMs, ensuring GLP and 21 CFR Part 11 compliance.

Agency

Department Of Defense → W6QK Acc-Apg

NAICS

541611 - Administrative Management and General Management Consulting Services View NAICS

Place of Performance

MD

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 → W6QK Acc-Apg
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Defense → W6QK Acc-Apg
Office AddressN/A
ContactsNo contact information available

Full Description

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Provide regulatory consulting to support FDA qualification of New Approach Methodologies (NAMs), ensuring data meets standards for use in lieu of animal testing and complies with GLP and 21 CFR Part 11.