gPROMS lyophilization Modeling Toolbox (or equal)
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA) is soliciting quotes for a Siemens gPROMS lyophilization Modeling Toolbox (or equal) to establish a new contract for an advanced process modeling and simulation platform. This Combined Synopsis/Solicitation is issued as an RFQ under FAR Part 13. Quotes are due May 20, 2026, by 1:00 PM EST.
Scope of Work
The FDA requires an advanced lyophilization process modeling and simulation platform to study emerging pharmaceutical manufacturing technologies. Key requirements for the Lyophilization Modeling Toolbox include:
- Nonlinear Predictive Control (NL) for Lyophilization: Utilizing a highly parallelized, equation-oriented architecture for high-fidelity predictive modeling of time-dependent lyophilization cycles.
- Operational Intelligence & Data Integration: Must include a base system (e.g., XHQ) for aggregating and visualizing real-time operational data to support "Digital Twin" validation.
- High-Fidelity Dynamic Simulation: Capable of simulating transient process events and complex equipment dynamics using first-principles mathematical equations.
- Advanced Material & Thermodynamic Property Architecture: Supports modeling complex pharmaceutical formulations with comprehensive databases.
- Automated Global System Analysis (GSA): Built-in tools for parameter estimation and Global Sensitivity Analysis to validate Quality by Design (QbD) design spaces.
- Customizable Modeling Environment & API: Features an open, equation-oriented language for custom models and a robust API for integration with external systems.
- Scalable Enterprise Access: Supports flexible licensing types including "Named User" and "Small System" base configurations.
- Regulatory-Grade Maintenance and Support: Provided through a multi-year subscription model including continuous enhancement and technical support.
Maintenance and Technical Support must include email/web conference support, upgrades, and one day of project support. Training requires access to online material.
Contract Details
- Contract Type: Firm Fixed-Price Order
- Period of Performance: One 12-month period, from July 10, 2026, to July 9, 2027.
- Delivery Schedule: No later than 30 days after contract award.
- Place of Performance: U.S. Food and Drug Administration, Silver Spring, MD.
Submission & Evaluation
- Submission Deadline: May 20, 2026, by 1:00 PM EST.
- Questions Deadline: May 13, 2026, by 1:00 PM EST.
- Submission Method: Electronically via email to terina.hicks@fda.hhs.gov.
- Evaluation Criteria: Lowest Price Technically Acceptable (LPTA). Evaluation will consider meeting technical requirements, installation/setup/training offering, authorized manufacturer distributor/reseller status, past performance, and ability to deliver within 30 days. Quotes must meet all requirements to be technically acceptable.
Eligibility / Set-Aside
- Competition Type: Full and Open Competition / Brand Name or Equal.
- Reseller Requirement: Offeror must be an Original Equipment Manufacturer, authorized reseller, and/or servicing agent of the software manufacturer.
Additional Notes
This is a combined synopsis/solicitation; no separate written solicitation will be issued. The FDA staff will install the software. Quotes must be submitted without macros, and offerors must provide detailed point-by-point descriptions of how their product meets the salient characteristics.