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This Subcontract opportunity from Department Of Health And Human Services was posted on July 10, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Regulatory Compliance and Validation Support

Closed
Federal

Contract Overview

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

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NAICS: 541611
New
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Hagerty Consulting, Inc.

POSTED

about 1 hour ago

DEADLINE

in 4 days
NAICS: 541611
New
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Solicitation # REWIRESTATE
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about 7 hours ago

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AI Contract Overview

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The contract seeks consulting services to support compliance with 21 CFR Part 11, focusing on system validation, documentation, and audit readiness for regulated environments. The scope includes developing and implementing IQ, OQ, and PQ protocols, providing audit support, and ensuring all validation activities meet federal regulatory standards. The work is intended to strengthen the integrity and compliance posture of systems used in clinical and research operations under the oversight of the National Institutes of Health. This subcontract is posted under the NAICS code 541611 for management consulting services and is performance-based at the Bethesda, Maryland location with a response deadline of July 21, 2026. The contracting activity is aligned with the Department of Health and Human Services and targets contractors with proven expertise in pharmaceutical and biotech regulatory environments. All deliverables must align with FDA expectations for electronic records and signatures, requiring a technical approach that combines thorough documentation, validated methodologies, and a clear understanding of current regulatory guidance.

General Info

Consulting for 21 CFR Part 11 compliance, validation, audit readiness, and FDA-aligned system support in NIH-regulated environments.

NAICS

541611 - Administrative Management and General Management Consulting Services

Place of Performance

Bethesda, MD, 20892, USA

Set-Aside

NONE

Documents

This scope was carved out of 75N98026Q00775.

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

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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 Health And Human Services → National Institutes Of Health Olao
ContactsNo contacts available
OfficeN/A
Office AddressN/A
ContactsNo contact information available

Full Description

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Provide consulting services for 21 CFR Part 11 compliance, including system validation, documentation, audit support, and development of IQ/OQ/PQ protocols.

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