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Regulatory Review Support

Active

Federal

Contract Overview

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

AI Contract Overview

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The contract titled Regulatory Review Support is positioned to provide targeted orientation and instruction to regulatory reviewers within the Center for Drug Evaluation and Research at the Food and Drug Administration. The primary purpose is to equip these reviewers with the necessary knowledge and proficiency to effectively utilize specialized, customized tools, systems, and services that have been jointly developed with review offices to enhance and streamline the regulatory review process. This support is designed to ensure seamless integration of technology and process improvements into daily workflows, thereby increasing efficiency and consistency in drug evaluation activities. The solicitation is forecasted under NAICS code 541990, indicating it falls under Other Scientific and Technical Consulting Services, and is managed by the FDA with no set-aside provisions specified. The point of contact for program inquiries is the CDER Acquisition Liaison, reachable at cderacquisitions@fda.hhs.gov, while the contracting officer position remains listed as to be determined. The contract’s place of performance and specific location details are not provided, and the opportunity was posted on May 25, 2026, with further information accessible via the FDA’s official procurement portal.

General Info

Provide specialized training for FDA CDER regulatory reviewers using customized tools and systems.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541990 - All Other Professional, Scientific, and Technical ServicesView NAICS

Place of Performance

US

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PostedMay 25

forecast

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / Agency

Food and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cder Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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Provides orientation and instruction to CDER regulatory reviewers in CDER in the use of specialized/customized tools, systems, and services that are collaboratively with review offices to support the review process.

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