Name | Type | Posted | Actions |
|---|---|---|---|
Intent to Sole Source FDA-75F40126Q00155.pdf | May 22, 2026 |
INTENT TO SOLE SOURCE gPROMS Lyophilization Modeling Toolbox (or equal)
Contact and place of performance
Terina Hicks
Silver Spring, MD 20993
USA
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.
The Food and Drug Administration (FDA), specifically the Center for Drug Evaluation and Research (CDER) and the Office of Pharmaceutical Quality Research (OPQR), requires an advanced lyophilization process modeling and simulation platform. This software is intended to support the study of emerging pharmaceutical manufacturing technologies. The agency has issued this special notice, solicitation number FDA75F40126Q00155, to announce its intent to sole source the gPROMS Lyophilization Modeling Toolbox or a functional equivalent.
This requirement is classified under NAICS 513210 Software Publishers and PSC DH10 IT and Telecom - Platform as a Service: Database, Mainframe, Middleware. The procurement has no set-aside designated. Performance will take place in Silver Spring, Maryland, and the primary point of contact is Terina Hicks. One attachment, a PDF titled Intent to Sole Source FDA-75F40126Q00155, was published with the notice on May 22, 2026. Responses to this notice must be submitted by the deadline of June 2, 2026.
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