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(3) Mechanical Qualification for Dissolution Tender, USA - 104801287

HEALTH AND HUMAN SERVICES, DEPARTMENT OF has floated a tender for (3) Mechanical Qualification for Dissolution. The project location is USA and the tender is closing on 01 Aug 2024. The tender notice number is 24Q1277832, while the TOT Ref Number is 104801287. Bidders can have further information about the Tender and can request the complete Tender document by Registering on the site.

Procurement Summary

Country : USA

Summary : (3) Mechanical Qualification for Dissolution

Deadline : 01 Aug 2024

Other Information

Notice Type : Tender

TOT Ref.No.: 104801287

Document Ref. No. : 24Q1277832

Competition : ICB

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is FDA-RFQ-24Q1708340. This requirement is issued as Request for Quote (RFQ). The solicitation is issued as a Full and Open competition. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC-2024-05, Effective 05/22/2024. The associated North American Industry Classification System (NAICS) Code is 334516 with a small business size standard of 1000 employees. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the requirements herein.

BACKGROUND

The U.S. Food and Drug Administration (FDA), New York Laboratory Medical Products in the Office of Regulatory Science, Office of Medical Products and Specialty Laboratory Operations, located at 158-15 Liberty Avenue, Jamaica, NY 11433 (Lead Laboratory for this request). The system in use needs to maintain cGMP/cGLP, ISO/IEC 17025-2005, ISO 9001:2008, and 21 CFR 11 standards for use as analytical equipment under the current accreditation. The dissolution system is used to evaluate the rate and extent that a compound forms a solution, typically, for drug samples using specific protocols and methods established by USP monographs. Dissolution testing is performed with apparatus described in General Chapter Dissolution.

OBJECTIVE The purpose of this acquisition is to acquire (3) Mechanical Qualification of Dissolution

REQUIREMENTS

All the following system requirements are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the p...
Active Contract Opportunity Notice ID 24Q1277832 Related Notice Department/Ind. Agency HEALTH AND HUMAN SERVICES, DEPARTMENT OF Sub-tier FOOD AND DRUG ADMINISTRATION Office FDA OFFICE OF ACQ GRANT SVCS
General Information
Contract Opportunity Type: Combined Synopsis/Solicitation (Original)
All Dates/Times are: (UTC-04:00) EASTERN STANDARD TIME, NEW YORK, USA
Original Published Date: Jul 25, 2024 08:28 am EDT
Original Date Offers Due: Aug 01, 2024 11:00 am EDT
Inactive Policy: 15 days after date offers due
Original Inactive Date: Aug 16, 2024
Initiative: None

Classification
Original Set Aside:
Product Service Code: 6632 - ANALYSIS INSTRUMENTS, MEDICAL LABORATORY USE
NAICS Code: 334516 - Analytical Laboratory Instrument Manufacturing

Place of Performance: Jamaica, NY 11433 USA