Intent to Sole Source FDA-75F40126Q00155.pdf

INTENT TO SOLE SOURCE

gPROMS Lyophilization Modeling Toolbox (or equal)

FDA – 75F40126Q00155

Date Posted: May 22, 2026

Response Date: June 2, 2026, 1:00 PM EST

Classification Code: DH10 – IT and Telecom – Platform As A Service: Database, Mainframe, Middleware

NAICS Code: 513210 – Software Publishers

The United States (US) Food and Drug Administration (FDA) intends to award a sole source, Firm Fixed

Price Purchase Order to Siemens Government Technologies, Inc., 2231 Crystal Dr, Suite 700, Arlington, Virginia 22202-3724, on a sole source base, under the authority of FAR 6.302-1, Only One Responsible

Source and No Other Supplies or Services Will Satisfy Agency Requirements.

The FDA / Center for Drug Evaluation and Research (CDER) / Office of Pharmaceutical Quality Research

(OPQR) requires to obtain an advanced lyophilization process modeling and simulation platform to study emerging pharmaceutical manufacturing technologies. This will be a 12-month period of performance for software license and support services.

The contractor shall provide the following salient characteristics:

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

Deliverables

Item No. Description Qty. Unit

Lyophilization Modeling

Toolbox for 1 user

Months

Software and licensing key, Software and User Manuals or equal to in a digital copy provided on a CD, DVD or digital download. CD, DVD and hard copies of deliverables shall not be required to be returned to the Contractor.

Based on these unique qualifications, Siemens Government Technologies, Inc. is the only source available to provide advanced lyophilization process modeling and simulation platform, maintenance, technical support, and training to the FDA/CDER/OPQR that is not available from any other vendor. The service required is available from only one responsible source and no other type of service will satisfy the agency’s requirement.

This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(1) requiring the dissemination of information on proposed contract actions. This is a notice of intent to award a sole-source contract and is not a request for competitive proposals. The statutory authority for this sole-source procurement is FAR 6.302-1.

This notice of intent is not a request for competitive proposals. Interested parties that believes it can meet the requirement, may submit a capability statement to Terina Hicks at terina.hicks@fda.hhs.gov by June

2,2026, at 1:00 PM Eastern Standard Time (EST). A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. If no responsive statements mailto:terina.hicks@fda.hhs.gov are received before the closing date and time, an award will subsequently be made to Siemens Government

Technologies, Inc. No telephonic inquiries.