INTENT TO SOLE SOURCE gPROMS Lyophilization Modeling Toolbox (or equal)

SOL #: FDA75F40126Q00155Special NoticeSole Source

Overview

Buyer

Health And Human Services
Food And Drug Administration
FDA Office of Acquisitions and Grants Services
Rockville, MD, 20857, United States

Place of Performance

Silver Spring, MD

NAICS

Software Publishers (513210)

PSC

Platform Delivered As A Service For Databases And Middleware. A Distributed Platform, Application And System Integration Resources Enabling Cross Application Development, Communications And Information Sharing. (DH10)

Set Aside

No set aside specified

Timeline

1
Posted
May 22, 2026
2
Action Date
Jun 2, 2026, 5:00 PM

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) / Center for Drug Evaluation and Research (CDER) / Office of Pharmaceutical Quality Research (OPQR) has issued an Intent to Sole Source notice. The FDA intends to award a Firm Fixed Price Purchase Order to Siemens Government Technologies, Inc. for an advanced gPROMS Lyophilization Modeling Toolbox (or equal) to study emerging pharmaceutical manufacturing technologies. Interested parties must submit capability statements by June 2, 2026.

Scope of Work

The required Lyophilization Modeling Toolbox must provide an advanced lyophilization process modeling and simulation platform. Key characteristics include:

  • Nonlinear Predictive Control (NL) for Lyophilization
  • Operational Intelligence & Data Integration (e.g., XHQ for "Digital Twin" validation)
  • High-Fidelity Dynamic Simulation
  • Advanced Material & Thermodynamic Property Architecture
  • Automated Global System Analysis (GSA)
  • Customizable Modeling Environment & API
  • Scalable Enterprise Access (Named User and Small System licenses)
  • Regulatory-Grade Maintenance and Support
  • Training (online material)

Deliverables include the software license, software, and user manuals in digital format.

Contract & Timeline

  • Contract Type: Firm Fixed Price Purchase Order
  • Period of Performance: 12 months
  • Set-Aside: Sole Source (to Siemens Government Technologies, Inc.)
  • Capability Statement Due: June 2, 2026, at 1:00 PM EST
  • Published: May 22, 2026

Evaluation

This is a notice of intent to award a sole-source contract under FAR 6.302-1, not a request for competitive proposals. The FDA has determined that only one responsible source can satisfy the agency's requirements. However, interested parties who believe they can meet the requirement may submit a capability statement for consideration.

Additional Notes

  • NAICS Code: 513210 - Software Publishers
  • Product Service Code: DH10 – Platform Delivered As A Service For Databases And Middleware
  • No telephonic inquiries will be accepted. All communications should be via email to the primary contact.

People

Points of Contact

Terina HicksPRIMARY
terina.hicks@fda.hhs.gov

Files

Files

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Versions

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Special Notice
Posted: May 22, 2026
INTENT TO SOLE SOURCE gPROMS Lyophilization Modeling Toolbox (or equal) | GovScope