This Government Contract opportunity from Department Of Health And Human Services was posted on May 1, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Pharmaceutical Quality Assurance and Regulatory Compliance Services

Closed

Federal

Submission Closed05/06/2026, 01:00:00 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

The contract secures third-party services for comprehensive quality assurance, batch testing, and regulatory compliance verification of compounded intravenous narcotics, ensuring strict alignment with USP <797> for aseptic processing, USP <800> for hazardous drug handling, and FDA current Good Manufacturing Practices. The services are critical to maintaining patient safety and regulatory integrity throughout the compounding lifecycle, with all work performed at the designated place of performance in Bethesda, Maryland, under the oversight of the National Institutes of Health under the Department of Health and Human Services. The solicitation, posted on May 1, 2026, requires proposals to be submitted by May 6, 2026, at 1:00 PM, and is classified as a subcontract under NAICS code 541611 for scientific research and development services.

General Info

Third-party QA, batch testing, and regulatory compliance for IV narcotics per USP <797>, <800>, FDA cGMP in Bethesda, MD.

Agency

Department Of Health And Human Services → National Institutes Of Health OlaoView Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

Bethesda, MD, 20892, USA

Set-Aside

NONE

Documents

This scope was carved out of NOI-OD-26-000038.

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

View the prime solicitation

NOI to Sole Source to QuVa Pharma, Inc.

AI Contract Breakdown

Uniform Contract Format

No contract breakdown available.

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Timeline

PhaseClosed

PostedMay 1

subcontract

Response DeadlineMay 6

Deadline has passed

Submission Closed

05/06/2026, 01:00:00 PM UTC

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → National Institutes Of Health Olao

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Health And Human Services → National Institutes Of Health Olao

View Agency Profile

Office AddressN/A

ContactsNo contact information available

Full Description

Third-party quality assurance, batch testing, and regulatory compliance verification for compounded IV narcotics to ensure adherence to USP <797>, <800>, and FDA cGMP requirements.