Regulatory Review Support

Past New Requirement Updated

Agency
Solicitation expected
Estimated value
$700,000 to $1,500,000
Set-aside
No set-aside

Forecast facts

Anticipated award
NAICS code
541990 All Other Professional, Scientific, and Technical Services
Points of contact

Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.

About this forecast

The Department of Health and Human Services Food and Drug Administration (FDA) is forecasting a contract opportunity for regulatory review support services. The project will provide orientation and instruction to Center for Drug Evaluation and Research (CDER) regulatory reviewers in the use of specialized and customized tools, systems, and services that are collaboratively developed with review offices to support the review process. The estimated solicitation release date is November 1, 2025, with an anticipated contract award date of January 1, 2026.

While specific award values are not currently disclosed, the contract falls under NAICS code 541990 for All Other Professional, Scientific, and Technical Services. Potential contractors can contact Christopher Scott at christopher.scott@fda.hhs.gov for additional information. The point of contact email for general inquiries is listed as tbd@fda.gov, and the procurement will be managed through the Food and Drug Administration's procurement office.

Forecast text

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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