This firm-fixed-price delivery order was awarded by the Food and Drug Administration (FDA), a civilian agency within the Department of Health and Human Services, to Core Human Factors, Inc., a for-profit S-corporation. The $404,063 contract is to conduct a comparative use human factors study that evaluates whether certain user interface differences between pen-injector combination products affect user error rates among diabetic patients. This study is part of a larger $10,000,000 Indefinite...
This is a new task order awarded under an existing Indefinite Delivery Indefinite Quantity (IDIQ) contract (HHSF223201610004I) with the Department of Health and Human Services Food and Drug Administration (FDA). The task order, valued at $2,470,791.00, is for a Pharmacokinetic (PK) study of opioid drug products following oral ingestion of chewed products. The study falls under the FDA's In Vivo Study of Generic Drug Products in Human Subjects program. The contract is a Firm Fixed Price...
The U.S. Department of Health and Human Services Food and Drug Administration awarded a $6.9 million delivery order to Aeio LLC under the agency's FDA Human Resource Support Services 2017-2022 master indefinite-delivery, indefinite-quantity contract. The purpose of this task order is to provide human capital and human resources management support services to help ensure mutual understanding of objectives, roles, responsibilities, and timeframes related to efforts sponsored by the Center for Drug...
This is a 1.5-year, Time-and-Materials (T&M) task order awarded to Pn-Heitech, LLC, a minority-owned small business, to provide acquisition and management of medical device adverse event data services to support the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). The task order has a ceiling value of $12,836,604.29 and was awarded on September 18, 2025, with an ultimate completion date of March 13, 2027. Pn-Heitech, LLC is a small disadvantaged...
This is a 1.5-year, firm-fixed-price task order awarded by the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), to Pn-Heitech, LLC, a minority-owned small business. The $4,807,453.89 task order is for premarket and postmarket tracking services to support the CDRH's mission. Pn-Heitech, LLC holds a $103 million single award indefinite delivery contract with the FDA, and has previously provided the agency with services such as help desk support,...
This is a new task order awarded by the Food and Drug Administration (FDA) to Biopharma Services USA, Inc. under an existing contract (HHSF223201610004I) to perform a study titled "Evaluation of Formulation Dependence of Drug Interaction with Proton Pump Inhibitors (PPIs)." The task order is for an in vivo study of generic drug products in human subjects and has a not-to-exceed ceiling value of $1,320,689.00. The contract is a firm fixed price Delivery Order with a period of...
This is a $201,619 labor hour task order awarded by the Department of Health and Human Services' Food and Drug Administration to Koniag Management Solutions LLC. The task order was issued under an existing indefinite-delivery/indefinite-quantity (IDIQ) contract for characterization research support services to the FDA's Office of Pharmaceutical Quality laboratories located in Calverton, Maryland. Koniag will provide labor hours to assist with research characterization activities from May 2023...
This is a $62,820.10 Delivery Order issued under an Indefinite Delivery/Indefinite Quantity (ID/IQ) contract between the Food and Drug Administration (FDA) and Ihrc, Incorporated, a small disadvantaged, woman-owned business. The contract provides CDRH (Center for Devices and Radiological Health) Primary Barrier Equipment Support Services, including safety engineering, industrial hygiene, laboratory science, and occupational health and safety services for FDA facilities. The ID/IQ contract has...
This is a firm fixed price delivery order awarded by the Food and Drug Administration (FDA) to Source Healthcare Analytics LLC, a global provider of outsourced development services to the pharmaceutical, biotechnology, and medical device industries. The $13,119,440.00 contract is for the "ACCESS TO OUTPATIENT LONGITUDINAL DATA IDIQ TASK ORDER #1," which aims to procure real-world data to aid the FDA in monitoring drug safety and effectiveness. The award is not set aside and is part...
This is a firm fixed price delivery order awarded by the Food and Drug Administration (FDA) to Pn-Heitech, LLC, a minority-owned small business, for Center for Devices and Radiological Health (CDRH) premarket and postmarket tracking services. The total award value is $13,743,348.51 and the performance period runs through September 29, 2025. Pn-Heitech has previously received task orders against an Indefinite Delivery Contract with the FDA valued at up to $103 million for IT, medical device...