Regulatory Review Support
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- 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
-
- CDER Acquisition Liaison cderacquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is seeking a contractor to provide regulatory review support through orientation and instruction to CDER regulatory reviewers in the use of specialized and customized tools, systems, and services designed to support the drug review process. This new requirement represents a collaborative effort with review offices to enhance operational efficiency and reviewer competency. The solicitation is expected to be released on August 1, 2025, with an estimated contract award date of January 1, 2026.
The contract award value is estimated between $700,000 and $1,500,000, and the work will be performed within the FDA's CDER division. This opportunity falls under NAICS code 541990 (All Other Professional, Scientific, and Technical Services) and is not subject to any set-aside provisions. Interested parties should contact the FDA's Acquisition Liaison at cderacquisitions@fda.hhs.gov for additional information regarding this forecasted opportunity.
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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