Lyophilization Process Modeling Software Licensing

The contract seeks to procure and license commercial off-the-shelf lyophilization modeling software, such as gPROMS or an equivalent solution, to support high-fidelity dynamic simulations and the validation of digital twins within the FDA’s pharmaceutical quality systems. The software must enable precise modeling of lyophilization processes to enhance process understanding, control, and regulatory compliance, particularly in the context of advanced manufacturing and quality assurance initiatives. Licensing terms will ensure the software is fully functional and authorized for use in FDA-regulated environments, with capabilities to integrate into existing computational frameworks and support reproducible, science-based decision making. Performance of this contract is designated to occur in Silver Spring, Maryland, with a response deadline of May 20, 2026, and the solicitation was posted on May 6, 2026. The contract is classified as a subcontract under the NAICS code 511210, pertaining to software publishers, and is managed by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services. The acquisition is intended to strengthen the agency’s ability to evaluate and approve complex pharmaceutical manufacturing processes through advanced digital modeling tools, with no set-aside provisions specified. All selected solutions must meet rigorous technical and regulatory requirements to ensure alignment with FDA’s mission for product quality and public health protection.