SAM #75F40126Q00120

FDA Solicits Flowsheet Modeling and Simulation Software Licenses and Support

The FDA Center for Drug Evaluation and Research is seeking to acquire advanced flowsheet modeling and simulation software for pharmaceutical manufacturing process analysis. - Government Buyer: - U.S. Food and Drug Administration (FDA) - Center for Drug Evaluation and Research - Office of Pharmaceutical Quality / Office of Testing and Research Division of Product Quality Research - OEMs and Vendors: - gPROMS (explicitly mentioned as the reference OEM) - Equivalent platforms are permitted - Products/Services Requested: - Two (2) licenses for flowsheet modeling and simulation software (gPROMS or equal) - Must include model libraries for blending, granulation, milling, feeding, compression, tablet coating, oral absorption, crystallization, and drying - Includes software updates, defect response, feature upgrades - Includes maintenance, technical support, and one on-project training - Unique or Notable Requirements: - Software must support both dynamic and steady-state modeling of pharmaceutical processes - Focus on continuous manufacturing process simulation and quality assessment - Firm-fixed-price contract structure - Base year plus four one-year option periods (total of five years) - Place of Performance/Delivery: - FDA Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 64, Silver Spring, MD 20993

Description

The objective is to purchase a new license for gPROMS or equal to flowsheet modeling and simulation platform including model libraries for blending, granulation, milling, feeding, compression, tablet coating, oral absorption, crystallization, and drying.

See Attachement for complete details.

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued.

The Government is in no way obligated to make an award, nor to pay any costs incurred by the Contractor in preparing and submitting its quote.

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