Biorelevant characterization system for subcutaneous injections
ID: SSN_CDER-2025-126738Type: Sources Sought
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFFOOD AND DRUG ADMINISTRATIONFDA OFFICE OF ACQ GRANT SVCSBeltsville, MD, 20705, USA

NAICS

Analytical Laboratory Instrument Manufacturing (334516)

PSC

LABORATORY EQUIPMENT AND SUPPLIES (6640)

Original Source

https://sam.gov/opp/10e258ff3d2e4611adf907f893c344a7/view
Timeline
    Description

    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking vendors to provide a Biorelevant Characterization System for evaluating subcutaneous drug formulations. This system is intended to enhance the capabilities of the Center for Drug Evaluation and Research (CDER) by enabling the investigation of drug release performance under simulated physiological conditions, utilizing integrated sensors and automated operation for unattended assessments. The initiative underscores the FDA's commitment to ensuring the quality, safety, and efficacy of pharmaceutical products while promoting innovation and domestic manufacturing. Interested parties, particularly small businesses under NAICS Code 334516, are encouraged to submit their qualifications by contacting Erika Crawford at erika.crawford@fda.hhs.gov or Maria Finan at maria.finan@fda.hhs.gov, as this is a Sources Sought Notice for market research purposes only, with no contract to be awarded at this stage.

    Point(s) of Contact
    Erika Crawford
    (301) 796-0298
    erika.crawford@fda.hhs.gov
    Files
    Title
    Posted
    SSN_CDER-2025-126738_FINAL.pdf
    The FDA's Office of Acquisitions and Grants Services (OAGS) has issued a Sources Sought Notice for market research regarding a Biorelevant Characterization System aimed at enhancing the Center for Drug Evaluation and Research (CDER) capabilities. The FDA invites responses from all businesses, especially small enterprises, to seek vendors that can supply the specified system for evaluating subcutaneous drug formulations. Key requirements include a system with integrated sensors, automated operation, and the ability to conduct multiple independent assays in a simulated extracellular matrix environment. The notice includes detailed technical specifications such as system components, performance metrics, and post-warranty maintenance options. Additionally, all submissions must include specific company information and adhere to privacy protocols, as responses will be used to assess qualifications but are not considered formal proposals. This initiative is part of the FDA's ongoing commitment to ensuring the quality and efficacy of pharmaceutical products while promoting innovation and domestic manufacturing capabilities.
    Lifecycle
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    Type
    Biorelevant characterization system for subcutaneous injections
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