SAM #75F40126Q134239

FDA Solicitation for Subcutaneous Injection Site Simulator System and Support

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Review (CDER), Division of Pharmaceutical Quality Research V (DPQRV) is seeking to procure a specialized laboratory system: - Buyer: FDA, CDER, DPQRV - Product requested: One in vitro Subcutaneous Injection Site Simulator (SCISSOR) system - System must include: - Multiple independent chambers (minimum six) - Integrated optical detection systems - Automated sampling and injection - Fraction collection - Comprehensive software control - Compatibility with FDA's existing spectrophotometer system - Intended use: Regulatory research for complex long-acting injectable drug products and bioequivalence studies - Services required: - Complete installation (hardware, software, integration) - On-site and remote training for FDA personnel - Technical support during business hours, including remote diagnostics and software updates during warranty - Warranty: Minimum one-year manufacturer warranty from system acceptance - Notable requirements: - System must be delivered as a complete, integrated solution - Training and documentation must be comprehensive - Firm fixed-price contract; small business set-aside under NAICS 334516 - No specific OEMs or part numbers are named in the solicitation - All technical requirements are detailed in the solicitation attachment

Description

FDA's Division of Pharmaceutical Quality Research V (DPQRV) requires a subcutaneous injection site simulator (SCISSOR).  Please see the attached PDF file titled FDA 75F40126Q134239

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