RFQ 75F40126Q00091 Dual Dissolution

The FDA San Juan Medical Products Laboratory is soliciting a firm-fixed-price contract for the procurement, delivery, installation, and validation of a modern, dual bathless dissolution system with integrated autosampler, PC workstation, and controller software to replace its obsolete analytical equipment. The new system must fully comply with regulatory and quality standards including cGMP/cGLP, ISO/IEC 17025:2017, ISO 9001:2008, 21 CFR Part 11, and support analytical protocols from USP, FDA internal programs, the Department of Defense Shelf-Life Extension Program, and the Federal Contract Compliance program. The contract requires the equipment to be new, serialized, and accompanied by manufacturer certification, with delivery inside the FDA San Juan facility, installation, IQ/OQ validation, onsite training for up to five users, and comprehensive user manuals. A minimum three-year warranty covering parts, labor, travel, and software updates is mandated, including a 72-hour onsite response time. The entire delivery and installation process must be completed within six to eight weeks after award. The procurement is conducted under NAICS code 334516 and is set aside for total small business participation. Evaluation will be based on a balanced trade-off between technical approach and price, with the technical proposal addressing compliance with specifications, delivery schedule, warranty, training, and documentation quality. Pricing submissions must be itemized and fair, although no option periods are included. Invoices will be submitted electronically via the Department of Treasury’s Invoice Processing Platform. The contract incorporates standard FAR and federal Health and Human Services acquisition regulations, emphasizing domestic end products under Buy American provisions, and includes security prohibitions relevant to information systems but no specific clearance requirements. Offerors must submit proposals in two volumes—technical and price—meeting page limits and deadlines, with no discussions planned prior to award. The Government will perform inspection and acceptance at the San Juan laboratory, based on successful installation, validation, and compliance with the stated regulatory and quality standards.