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The HEALTH AND HUMAN SERVICES, DEPARTMENT OF | FOOD AND DRUG ADMINISTRATION has issued a Tender notice for the procurement of a Gproms Lyophilization Modeling Toolbox or Equal in the USA. This Tender notice was published on 07 May 2026 and is scheduled to close on 20 May 2026, with an estimated Tender value of Refer Document. Interested bidders can access detailed Tender information, eligibility criteria, and complete bidding documents by referencing TOT Ref No. 140810406, while the tender notice number is FDA-75F40126Q00155 and Registering on the platform.
Procurement Summary
Country: USA
Summary: Gproms Lyophilization Modeling Toolbox or Equal
Deadline: 20 May 2026
Posting Date: 07 May 2026
Other Information
Notice Type: Tender
TOT Ref.No.: 140810406
Document Ref. No.: FDA-75F40126Q00155
Competition: ICB
Financier: Self Financed
Purchaser Ownership: Public
Tender Value: Refer Document
Purchaser's Detail
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Login to see detailsTender Details
The objective is to establish a new contract for Siemens modeling and simulation platform license, featuring advanced process modeling.
FDA's OPQR has a requirement to obtain an advanced lyophilization process modeling and simulation platform to study emerging pharmaceutical manufacturing technologies. For Quoter-s software to be deemed acceptable, the following salient characteristics shall be met:
Lyophilization Modeling Toolbox
• Nonlinear Predictive Control (NL) for Lyophilization: Utilizes a highly parallelized, equation-oriented architecture optimized for high-performance computing (HPC) to perform large-scale, high-fidelity predictive modeling of time-dependent lyophilization cycles.
• Operational Intelligence & Data Integration: Must include a base system (such as XHQ) capable of aggregating and visualizing real-time operational data from multiple manufacturing sources to support "Digital Twin" validation.
• High-Fidelity Dynamic Simulation: Capable of simulating transient process events and complex equipment dynamics—including freezing, primary drying, and secondary drying—using first-principles mathematical equations rather than empirical data.
• Advanced Material & Thermodynamic Property Architecture: Supports the modeling of complex pharmaceutical formulations through comprehensive databases for excipients and APIs to track critical properties like moisture content and chemical purity throughout the stabilization process.
• Automated Global System Analysis (GSA): Built-in mathematical tools to perform parameter estimation from experimental data and Global Sensitivity Analysis (GSA) to identify influential process parameters and validate Quality by Design (QbD) design spaces.
• Customizable Modeling Environment & API: Features an open, equation-oriented language for creating custom first-principles models from scratch, complemented by a robust Application Programming Interface (API) for integration with external data systems like P...
Notice ID: fda-75f40126q00155
Department/Ind. Agency: health and human services, department of
Sub-tier: food and drug administration
Office: fda office of acq grant svcs
Product Service Code: dh10 - it and telecom - platform as a service: database, mainframe, middleware
NAICS Code: 513210 - Software Publishers
Inactive Dates: jun 04, 2026
Inactive Policy: 15 days after date offers due
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