Lyophilization Process Modeling Software Licensing

This contract involves the procurement and licensing of commercial off-the-shelf lyophilization process modeling software, such as gPROMS or an equivalent product, intended for use in high-fidelity dynamic simulations and digital twin validation. The software will support the FDA's pharmaceutical quality systems by enabling advanced modeling capabilities to improve the understanding and control of the lyophilization process. The contract is issued by the FDA's Office of Acquisition and Grant Services within the Department of Health and Human Services, with the place of performance designated in Silver Spring. The contract is categorized as a subcontract opportunity under NAICS code 511210, related to software publishing. It was posted on May 6, 2026, with a response deadline of May 20, 2026. While there is no specified set-aside, this opportunity targets suppliers capable of providing commercial software licenses that meet the FDA's technical requirements for pharmaceutical process modeling and digital twin applications. The arrangement will facilitate the agency's commitment to enhance quality assurance and regulatory review through the integration of cutting-edge simulation tools.