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

The FDA Center for Drug Evaluation and Research intends to sole-source award a 12-month purchase order to Siemens Government Technologies, Inc. for the gPROMS Lyophilization Modeling Toolbox software, with a June 2, 2026 deadline at 1:00 PM EST for capability statements from interested parties to challenge the sole-source determination.

The Office of Pharmaceutical Quality Research requires an advanced lyophilization process modeling and simulation platform to study emerging pharmaceutical manufacturing technologies. The award vehicle is a Firm Fixed Price Purchase Order under FAR 6.302-1 authority; solicitation number FDA-75F40126Q00155 (NAICS 513210, PSC DH10).

The required deliverable is a single-user license for 12 months with software licensing key, digital user manuals, nonlinear predictive control for lyophilization with HPC-optimized architecture, operational intelligence and data integration with Digital Twin validation support, high-fidelity dynamic simulation for freezing and drying phases, advanced thermodynamic property modeling for complex pharmaceutical formulations, automated Global System Analysis for parameter estimation and Quality by Design validation, customizable modeling environment with Python, Excel, and Electronic Lab Notebook API integration, and scalable enterprise access with flexible licensing. The contractor must provide email and web conference support, maintenance and system upgrades, one day of project support, and access to online training materials via Altair resources.

Interested parties must submit capability statements to Terina Hicks (terina.hicks@fda.hhs.gov). If no responsive capability statements are received by the June 2 deadline, the award will proceed to Siemens Government Technologies, Inc.