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Good Practice (GxP) Compliance Services

Active

Grant

Response Deadline11/16/2029, 05:00:00 AM UTC

Contract Overview

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

AI Contract Overview

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This subcontract for Good Practice (GxP) Compliance Services supports the National Institutes of Health and the Department of Health and Human Services by ensuring that laboratory and manufacturing processes for prime contractors on NIH/NEI research projects adhere to federal safety and quality standards. The scope of work involves the implementation and auditing of Good Manufacturing Practices, Good Laboratory Practices, and Good Clinical Practice guidelines. The selected provider must hold GxP auditing certification and is responsible for delivering compliance audit reports, Standard Operating Procedures, and certifications of compliance. This opportunity falls under NAICS code 541380 and has a response deadline of November 16, 2029.

General Info

GxP compliance services for NIH/HHS research projects, requiring certified auditing and reporting.

Agency

Department Of Health And Human Services → National Institutes Of Health

NAICS

541380 - Testing Laboratories and Services

Place of Performance

Not specified

Set-Aside

NONE

Documents

This scope was carved out of PAR-28-072.

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

View the prime solicitation

NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed)

AI Contract Breakdown

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Timeline

PostedSep 25

subcontract

Response DeadlineNov 16

Submission deadline

Response Deadline

11/16/2029, 05:00:00 AM UTCin about 3 years

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Health And Human Services → National Institutes Of Health

Office AddressN/A

ContactsNo contact information available

Full Description

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Ensures laboratory and manufacturing processes meet federal safety and quality standards for prime contractors on NIH/NEI research projects. Implements and audits Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practice (GCP) guidelines. Requires GxP auditing certification. Delivers compliance audit reports, Standard Operating Procedures (SOPs), and certifications of compliance.

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