This Government Contract opportunity from Department Of Health And Human Services was posted on May 29, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Regulatory Compliance and Validation Consulting

Closed

Federal

Submission Closed06/04/2026, 02:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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AI Contract Overview

This contract involves providing consulting services aimed at validating software to ensure it meets the stringent requirements for FDA regulatory use. The primary focus is on compliance with key regulations and guidelines, specifically 21 CFR Part 11, ALCOA+ principles, and ICH guidelines, all of which are crucial for maintaining data integrity and audit readiness within regulated environments. The work will support the Department of Health and Human Services through its Program Support Center Acquisition Management Service, emphasizing the significance of regulatory compliance in healthcare software. The contract, titled "Regulatory Compliance and Validation Consulting," is classified under NAICS code 541611, indicating management and consulting services. It is a subcontract opportunity posted on May 29, 2026, with a response deadline of June 4, 2026. The place of performance is Silver Spring, identified by the ZIP code 20903. While specific organizational and contact details are not provided, the contract is positioned to assist in ensuring that software systems are audit-ready and compliant with federal regulations, thereby supporting the overall mission of health regulatory adherence.

General Info

Consulting services for FDA software validation ensuring compliance with 21 CFR Part 11 and ALCOA+ guidelines.

Agency

Department Of Health And Human Services → Program Support Center Acq Management SvcView Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

Silver Spring, MD, 20903, USA

Set-Aside

NONE

Documents

This scope was carved out of 7571TE26Q00030.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

FDA Mechanistic Chromatography Modeling Software Software License Support and Maintenance Services

AI Contract Breakdown

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No contract breakdown available.

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Timeline

PhaseClosed

PostedMay 29

subcontract

Response DeadlineJun 4

Deadline has passed

Submission Closed

06/04/2026, 02:00:00 PM UTC

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → Program Support Center Acq Management Svc

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Health And Human Services → Program Support Center Acq Management Svc

View Agency Profile

Office AddressN/A

ContactsNo contact information available

Full Description

Consulting services to validate the software for FDA regulatory use, ensuring compliance with 21 CFR Part 11, ALCOA+, and ICH guidelines for data integrity and audit readiness.