FDA Mechanistic Chromatography Modeling Software Software License Support and Maintenance Services

The U.S. Food and Drug Administration, through the Department of Health and Human Services, is soliciting a firm-fixed-price contract for the procurement of a mechanistic chromatography modeling and simulation software platform under the brand name GoSilico or an equally capable alternative, along with associated license support and maintenance services. The solicitation, issued under a combined synopsis/solicitation pursuant to a FAR 12 RFO deviation, targets commercial products and services with a one-year period of performance beginning around June 25, 2026, and ending June 24, 2027. All deliverables, including the software license, licensing keys, and associated documentation, must be provided digitally via CD, DVD, or direct download. The software is required to support adsorption isotherms models across multiple chromatography modes and simulate fluid flow effects within chromatography columns, aligned with the Office of Pharmaceutical Quality Research’s mission to advance emerging pharmaceutical manufacturing technologies. Compliance with Section 508 of the Rehabilitation Act is mandatory, requiring all electronic content and system functionality to meet accessibility standards verified using FDA-approved tools, with final deliverables accompanied by the appropriate HHS 508 checklist unless formally waived. The contract imposes strict administrative, security, and procedural requirements. Offerors must be registered in the System for Award Management with active entity-level representations and certifications, and must comply with multiple FAR and HHS-specific clauses, including whistleblower protections, cybersecurity safeguards, and electronic payment submission via the Treasury’s Invoice Processing Platform, which mandates digital invoicing with written exceptions requiring formal authorization. Quotations must explicitly affirm acceptance of all solicitation terms or list specific exceptions with justification; rejection of terms will result in exclusion. Evaluation will follow a lowest price technically acceptable methodology, where technical acceptability and terms compliance are mandatory pass/fail thresholds. Delivery must occur within 15 days of award, with installation performed solely by FDA staff—no vendor on-site installation is permitted. The Government has 30 working days post-delivery to inspect and validate software operation, functionality, and compatibility with FDA server environments using sample project files. All submissions must be emailed to Chantal Cornelius by the June 4, 2026 deadline, and inquiries must also be directed via written email. The place of performance is Silver Spring, Maryland, with shipping to Beltsville, Maryland, under an unrestricted acquisition using NAICS code 541519 and Product Code 7A21 for perpetual license software.