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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

Closed
75F40125Q00458Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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AI 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

FDA seeks integrated PATs and digital twin platform for lyophilization process, proposals due September 2025.

NAICS

541519 - Other Computer Related Services

Place of Performance

MD, USA

Set-Aside

NONE

Documents

1

FDA RFQ 75F40125Q00458 - Integration platform of PATs and digital twin for Lyophilization

PDF, High priority: read this firstrfq
High

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Timeline

1 update
PhaseClosed
Posted

Combined Synopsis

Notice updated

Set-aside changed from No Set aside used to Total Small Business Set-Aside (FAR 19.5).

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acquisitions And Grants Services
Contacts1 person available
OfficeRockville, MD, 20857, USA

Full Description

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Integration platform of PATs and digital twin for Lyophilization This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in subpart 12.6, as supplemented with additional information included in this Request of Quotation. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

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