Project Information

Bid Title

gPROMS lyophilization Modeling Toolbox (or equal)

Issuing Agency

HEALTH AND HUMAN SERVICES, DEPARTMENT OF

Location

Maryland

Published Date

May 6, 2026

Closing Date

May 20, 2026

Government Level

Federal

Status

Closed

Ref. #

FDA-75F40126Q00155

Original Source

Join to Access Full Details

Bid Inquiries

Join to Access Full Details

Bid Documents

Join to Access Full Details

Set Aside

No Set aside used

Project Description

Follow

gPROMS lyophilization Modeling Toolbox (or equal)

Active

Contract Opportunity

Notice ID

FDA-75F40126Q00155

Related Notice

Department/Ind. Agency

HEALTH AND HUMAN SERVICES, DEPARTMENT OF

Sub-tier

FOOD AND DRUG ADMINISTRATION

Office

FDA OFFICE OF ACQ GRANT SVCS

Looking for contract opportunity help?

(opens in new window)

APEX Accelerators are an official government contracting resource for small businesses. Find your local APEX Accelerator (opens in new window) for free government expertise related to contract opportunities.

APEX Accelerators are funded in part through a cooperative agreement with the Department of Defense.

The APEX Accelerators program was formerly known as the Procurement Technical Assistance Program (opens in new window) (PTAP).

General Information

• Contract Opportunity Type: Combined Synopsis/Solicitation (Original)
• Original Published Date: May 06, 2026 10:43 am EDT
• Original Date Offers Due: May 20, 2026 01:00 pm EDT
• Inactive Policy: 15 days after date offers due
• Original Inactive Date: Jun 04, 2026
• Initiative:
  • None

Classification

• Original Set Aside: No Set aside used
• Product Service Code: DH10 - IT AND TELECOM - PLATFORM AS A SERVICE: DATABASE, MAINFRAME, MIDDLEWARE
• NAICS Code:
  • 513210 - Software Publishers
• Place of Performance:
  Silver Spring , MD 20993
  USA

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.

Attachments/Links

Contact Information

Contracting Office Address

• 11601 Landsdown St Floor 13
• Rockville , MD 20852
• USA

Primary Point of Contact

• Terina Hicks
• terina.hicks@fda.hhs.gov

Secondary Point of Contact

History

• May 06, 2026 10:43 am EDTCombined Synopsis/Solicitation (Original)

Commodity Codes

• FSC DAutomatic Data Processing and Telecommunication Services

* Disclaimer: Government BidHub provides information on bids, RFPs (Requests for Proposals), and RFQs (Requests for Qualifications) solely for convenience and informational purposes. This site is not an official public notice board. For official details, responses, or inquiries, please contact the relevant government agency directly.