Flowsheet modeling and simulation software license support and maintenance

The Food and Drug Administration's Center for Drug Evaluation and Research is soliciting quotations for a flowsheet modeling and simulation software license, specifically seeking gPROMS or an equivalent platform to support the evaluation of continuous pharmaceutical manufacturing technologies. The FDA requires two software licenses enabling users to conduct dynamic system modeling across pharmaceutical manufacturing processes including blending, granulation, milling, feeding, compression, tablet coating, oral absorption, crystallization, and drying operations. Quoters must demonstrate that their proposed solution meets 37 salient characteristics spanning flowsheet modeling environments with graphical interfaces, steady-state and dynamic process models, custom modeling capabilities, parameter estimation, sensitivity analysis, physical property estimation, optimization functions, and mechanistic model libraries. Award will be made to the lowest price technically acceptable quoter that meets all salient characteristics, period of performance, and quantity requirements as specified in the combined synopsis/solicitation. The quotation submission deadline is April 27, 2026, with this announcement constituting the only solicitation under FAR Part 12 procedures for commercial items.

This is an unrestricted full and open competition with no set-aside designations, and no incumbent contractor information is identified in the solicitation. The base contract performance period runs from July 12, 2026 through July 11, 2027, with four optional one-year extension periods available through July 11, 2031, allowing for potential five-year contract duration. Quoters must submit firm-fixed-price proposals for both the base year and all four option years, with payment terms of Net 30 following Government acceptance. Deliverables include software licensing keys and user manuals in digital format, with maintenance and technical support requirements encompassing software updates, one business-day response to defect inquiries, feature upgrade availability, and one on-project training session. The place of performance is located in Silver Spring, Maryland 20993, with the Government reserving 30 working days to inspect and verify operational functionality and compatibility with FDA systems.