INTENT TO SOLE SOURCE gPROMS Lyophilization Modeling Toolbox (or equal) FDA75F40126Q00155
Summary
AI-generated · May 23, 2026Intends to sole-source the procurement of an advanced lyophilization process modeling and simulation platform to study emerging pharmaceutical manufacturing technologies (gPROMS Lyophilization Modeling Toolbox or an equivalent). An “or equal” platform may be considered if it meets the requirements; see the attached Intent to Sole Source FDA-75F40126Q00155 document for more information.
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.
From Special Notice posted on May 22, 2026Notice history
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Place of Performance
USA