SAM #FDA75F40126Q00155

FDA Sole Source for gPROMS Lyophilization Modeling Toolbox License, Support, and Training

The FDA's Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research (OPQR), is seeking to procure an advanced lyophilization process modeling and simulation platform for pharmaceutical manufacturing research. - The intended procurement is a 12-month license for the gPROMS Lyophilization Modeling Toolbox, including: - Software license for one user - Maintenance, technical support, and upgrades - One day of project support - Access to online training materials - The planned award is a sole source contract to Siemens Government Technologies, Inc., but the notice allows for equivalent solutions. - The software will support high-fidelity modeling, simulation, and operational intelligence for lyophilization processes in pharmaceutical manufacturing. - No specific part numbers are provided; the requirement is for a sophisticated, research-grade modeling tool. - The primary place of performance is Silver Spring, MD, with the FDA contracting office located in Rockville, MD.

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.

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