FDA Mechanistic Chromatography Modeling Software Software License Support and Maintenance Services
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. Department of Health and Human Services (HHS), on behalf of the Food and Drug Administration (FDA), is soliciting quotes for Mechanistic Chromatography Modeling Software License Support and Maintenance Services. This opportunity seeks a brand name or equal solution to GoSilico software, providing essential tools for drug development and CMC applications. The government intends to award a firm fixed-price purchase order. Quotes are due by June 4, 2026, at 10:00 AM Eastern Daylight Time.
Scope of Work
The requirement is for software license support and maintenance services for mechanistic chromatography modeling software. Key features include a comprehensive modeling environment with a graphical interface, streamlined workflow, seamless integration with lab systems (AKTA, UNICORN), and visual tools for output interpretation. The software must support component-centric data structures, tamper-proof data management, simulation of preparative liquid chromatography, creation of digital twins, and custom modeling capabilities applicable to various molecules and development stages. Services also include software updates, one-business-day response to defect inquiries, feature upgrades, and standardized 3-day vendor training. Deliverables include the software, licensing key, and digital user manuals.
Contract & Timeline
- Contract Type: Firm Fixed-Price Purchase Order
- Period of Performance: 12 months, approximately June 25, 2026, to June 24, 2027.
- Set-Aside: Unrestricted Basis
- NAICS Code: 541519 (Other Computer Related Services)
- Product Service Code: 7A21 (IT and Telecom - Business Application Software)
- Questions Due: June 2, 2026, 10:00 AM EDT
- Submission Deadline: June 4, 2026, 10:00 AM EDT
- Published Date: May 29, 2026
Evaluation
Quotes will be evaluated on a Lowest Price Technically Acceptable (LPTA) basis. Quoted items must meet all specifications outlined in the solicitation to be considered technically acceptable.
Additional Notes
This is a combined synopsis/solicitation utilizing simplified procedures pursuant to FAR 12.201-1. Offerors must submit all quotations via email to Chantal Cornelius (chantal.cornelius@hhs.gov). Section 508 accessibility standards apply, and offerors must complete entity-level representations and certifications in SAM.gov.