INTENT TO SOLE SOURCE gPROMS Lyophilization Modeling Toolbox (or equal)

Name: INTENT TO SOLE SOURCE gPROMS Lyophilization Modeling Toolbox (or equal)
Creator: HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Published: 2026-05-22
License: https://creativecommons.org/publicdomain/zero/1.0/

Special NoticeNo Set AsideActive

Key Takeaways

Set-aside for No Set Aside businesses
Work to be performed in Rockville, MD
Industry: Software Publishers

Contract Details

Notice ID: FDA75F40126Q00155
Opportunity Type: Special Notice
Agency: HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-Agency: FOOD AND DRUG ADMINISTRATION
Office: FDA Office of Acquisitions and Grants Services
Posted Date: Friday, May 22, 2026
Response Deadline: Tuesday, June 2, 2026
NAICS Code: 513210 - Software Publishers
PSC Code: DH10
Set-Aside: No Set Aside
Place of Performance: Rockville, MD, 20857
Status: Active

View on SAM.gov

Description

The FDA / Center for Drug Evaluation and Research (CDER) / Office of Pharmaceutical Quality Research (OPQR) requires to obtain an advanced lyophilization process modeling and simulation platform to study emerging pharmaceutical manufacturing technologies. Please review the attached Intent to Sole Source FDA-75F40126Q00155 document for more information.

Why This Opportunity Matters

HEALTH AND HUMAN SERVICES, DEPARTMENT OF is seeking responses for software publishers with a set-aside for No Set Aside businesses in Rockville, MD. This set-aside designation means eligible businesses face reduced competition from larger firms.

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