This Combined Synopsis/Solicitation opportunity from Department Of Health And Human Services was posted on May 6, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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gPROMS lyophilization Modeling Toolbox (or equal)

Closed

FDA-75F40126Q00155Federal

Submission Closed05/20/2026, 05:00:00 PM UTC

Contract Overview

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

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NAICS: 513210

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AI Contract Overview

The contract seeks to establish a licensing agreement for an advanced modeling and simulation platform tailored to lyophilization processes, specifically designed for the FDA’s Office of Pharmaceutical Quality Research. The platform must offer high-fidelity, first-principles-based dynamic simulation capabilities to accurately model complex pharmaceutical drying cycles, including freezing and drying phases. Essential features include nonlinear predictive control optimized for high-performance computing, real-time operational data integration to support digital twin validation, and comprehensive databases to model pharmaceutical formulations and critical properties throughout processing. Additional requirements encompass automated tools for global sensitivity analysis and parameter estimation to support Quality by Design initiatives, as well as an open, customizable modeling environment with robust API integration options for external systems. Maintenance, support, and upgrades are defined as ongoing necessities under a multi-year subscription model, with support provided through email or web conference, and include at least one day of project assistance. Training access must be delivered via online resources through Altair. The licensing agreement is expected to accommodate scalable enterprise access with flexible licensing types to suit different user needs. The contract is classified under NAICS 513210, managed by the FDA’s Office of Acquisition and Grant Services with performance located in Maryland. The solicitation emphasizes regulatory-grade support to ensure alignment with established software designation agreements and continuous enhancements over the contract term.

General Info

Licenses advanced lyophilization simulation platform with real-time data, support, training, and scalable enterprise access.

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant Svcs

NAICS

513210 - Software PublishersView NAICS

Place of Performance

Silver Spring, MD, 20993, USA

Set-Aside

NONE

Documents

(1)

RFQ FDA-75F40126Q00155 gPROMS Lyophilization Modeling Toolbox

PDF•rfq

AI Contract Breakdown

Uniform Contract Format

Timeline

PhaseClosed

PostedMay 6

Combined Synopsis

Response DeadlineMay 20

Deadline has passed

Submission Closed

05/20/2026, 05:00:00 PM UTC

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

Contacts1 person available

OfficeRockville, MD, 20852, USA

Organization / Agency

Department Of Health And Human Services → FDA Office Of Acq Grant Svcs

Office AddressRockville, MD, 20852, USA

Contacts

Terina Hicks

contact@example.gov

Full Description

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 Python, Excel, or Electronic Lab Notebooks.
• Scalable Enterprise Access: Supports flexible licensing types including "Named User" for specific researchers and "Small System" base configurations to manage data exchange across physical or virtual assets.
• Regulatory-Grade Maintenance and Support: Provided through a multi-year subscription model that includes continuous software enhancement, technical support, and alignment with established Licensed Software Designation Agreements (LSDA).

Maintenance and Technical Support
At minimum the contractor must:
• Provide support via email and/or web conference.
• Licenses shall include maintenance, support, and any upgrades necessary to maintain the system.
• Provide one day of project support.

Training
The Contractor shall provide:
• Access to online training material in Altair resources

Please review the attached RFQ_FDA-75F40126Q00155 document for all details.