The U.S. Food and Drug Administration (FDA) has awarded a $4,481,143.91 Delivery Order contract to Agisol LLC, an 8(a) certified small disadvantaged business, for CDER Streamline Process and Enhance Functions for New Drug Review. This is a Time and Materials contract awarded under the GSA Multiple Award Schedule (MAS) vehicle. Agisol LLC is a small IT services provider that specializes in supporting the FDA's regulatory review and research activities, including work on systems like the...
<p>The U.S. Food and Drug Administration (FDA) awarded a $42,520.00 firm fixed-price purchase order contract to Steq America, LLC, a small business, for the provision of a "BIODIS DISSOLUTION TESTER RRT 10 USP METHOD 3 7 METHOD CHANGEABLE BY USER W 8 ROWS INCL INSTALLATION AND TRAINING". The contract has a completion date of September 30, 2016. This contract appears to be for a specialized piece of laboratory equipment used in the FDA's regulatory and research activities.</p>
The Department of Health and Human Services Food and Drug Administration awarded a $727,122.40 firm fixed price purchase order to 3T Federal Solutions LLC of Austin, Texas. The contract calls for delivery of an automated high throughput patch clamp system to support the FDA's efforts to characterize drug effects on heart ion channels. The system must meet technical performance requirements to electrophysiologically assess individual cells at high volume, as requested in the small business...
The Department of Health and Human Services Food and Drug Administration (HHS FDA) awarded a firm-fixed price purchase order to Sotax Corp, doing business as Sotax AG, for the purchase and delivery of two United States Pharmacopeia (USP) 1 & 2 Dissolution Apparatus, including installation qualification (IQ), operational qualification (OQ), and mechanical qualification (MQ) services. The total potential value of the contract is $235,940.00, and the period of performance runs through August...
The Department of Health and Human Services Food and Drug Administration (HHS FDA) awarded a firm fixed-price purchase order contract to Erweka America Inc., a small disadvantaged, woman-owned business, to procure an instrument update for the existing ERWEKA DRT-3 chewing apparatus. The objective is to enable the in vitro characterization of abuse-deterrent opioid formulations designed to deter abuse by chewing. The total potential value of the contract is $24,274.37, and the period of...
The Food and Drug Administration (FDA) awarded a $302,299.06 firm fixed-price purchase order to Fedpoint Systems LLC, an 8(a) certified economically disadvantaged women-owned small business (EDWOSB), to provide a preventative maintenance agreement (PMA) for an HPLC and LC-Orbitrap mass spectrometer system. The contract has a base year (12 months) and four 1-year option periods, with a total period of performance through September 8, 2026. This award was made directly to Fedpoint Systems...
The Food and Drug Administration (FDA) awarded a $947,868.05 firm-fixed-price purchase order to Government Scientific Source Inc., a small business, for the delivery of a high-resolution ion mobility-high resolution mass spectrometer (HRIM-HRMS) system. This system will expand the FDA's analytical capabilities for ensuring the safety and efficacy of complex drugs like biologics, peptides, and oligonucleotides. The contract has a completion date of January 31, 2024 and includes training,...
The U.S. Food and Drug Administration (FDA) Office of Acquisition and Grants Services (OAGS) awarded a firm-fixed-price purchase order contract to Measurements Inc., a for-profit organization, for CDRH-2024-122027 Leakage Testing in Microfluidic Devices. The contract has a ceiling value of $29,486.00 and a completion date of July 4, 2025. The contract was not set aside for any specific business type. The contract originated from a solicitation posted on May 23, 2023, with a due date of June...
This is a 1-year, firm-fixed price purchase order awarded by the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), to Malvern Panalytical Inc. to provide a laser diffraction system to support the agency's testing and research on nonprescription spray drug products. The procurement, which follows FAR Part 12 and Part 13 procedures for commercial products and services, has a ceiling value of $150,052.01 and does not utilize a small business set-aside. The...
The Food and Drug Administration (FDA) awarded a $65,309.12 firm-fixed-price research and development contract to Photosound Technologies, Inc., a for-profit manufacturer based in Houston, Texas. The contract is for the delivery of a multi-channel data acquisition platform specifically designed for photoacoustic imaging (PAI) applications to support the FDA's regulatory science research on optical imaging systems. The system must meet stringent technical requirements, including at least 128...