This Combined Synopsis/Solicitation opportunity from Department Of Health And Human Services was posted on September 19, 2025. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
Integration platform of PATs and digital twin for Lyophilization
Contract Overview
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The contract involves the development and integration of a platform that combines Process Analytical Technologies (PATs) and a digital twin specifically for lyophilization processes. It is a sole-source solicitation issued by the FDA Office of Acquisitions and Grants Services, with the purpose of acquiring commercial products or services to enhance the FDA's capabilities in monitoring and optimizing lyophilization operations through advanced digital solutions. The solicitation was posted on September 19, 2025, with a response deadline of September 23, 2025, and is open to all qualified vendors without any set-aside restrictions. The NAICS code associated with this procurement is 541519, indicating a focus on other computer related services. Interested parties are directed to contact Lilibeth Deato via email or phone for further details, and additional information about the solicitation can be accessed through the provided link on SAM.gov. The contract aims to support the FDA's mission by leveraging innovative digital tools to improve process control and validation in pharmaceutical manufacturing, specifically in lyophilization, which is critical for ensuring drug stability and efficacy.
General Info
Place of Performance
MD, USASet-Aside
Documents
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Timeline
Submission Closed
Organization & Contact Information
Full Description
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