Tender Details

Country: USA
Summary: Biorelevant characterization system for subcutaneous injections
UST Ref No: 117369335
Deadline: 18 Apr 2025
Financier: Self Financed
Purchaser Ownership: Government
Tender Value: Refer Document
Notice Type: Tender
Document Ref. No.: SSN_CDER-2025-126738
Purchaser's Detail:
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Description:
Description
THIS IS A SOURCES SOUGHT NOTICE FOR MARKET RESEARCH PURPOSES ONLY. IT IS NOT A SOLICITATION FOR PROPOSALS, AND NO CONTRACT WILL BE AWARDED. THE FDA WILL NOT REIMBURSE COSTS ASSOCIATED WITH RESPONDING. TELEPHONE INQUIRIES WILL NOT BE ACCEPTED, AS THERE IS NO RFQ OR SOLICITATION. TO MAINTAIN PROCUREMENT INTEGRITY, NO TECHNICAL CONTACT INFORMATION OR PRESENTATION APPOINTMENTS WILL BE PROVIDED.
The FDA Office of Acquisitions and Grants Services (OAGS), on behalf of Center for Drug Evaluation and Research (CDER), seeks vendors who can provide a Biorelevant Characterization System and a domestic product offering. Responses from both small and large businesses are welcome.
If your firm is a small business under NAICS Code 334516 (Analytical Laboratory Instrument Manufacturing) with 1,000 employees or fewer and can provide the required supplies/services, please email Erika.Crawford@fda.hhs.gov and maria.finan@fda.hhs.gov.Background: FDA/CDER needs a Biorelevant Characterization System with 4 one-year post-warranty maintenance options. The system is for subcutaneous injections at the injection site in an artificial extracellular matrix (ECM) with integrated camera and turbidity sensors, inline fiber optic probes, pH monitors, and an automated sample fraction collector for unattended operation and media refill after sampling. The aim is to expand and augment the capacity and capability of CDER Office of Pharmaceutical Quality (OPQ)/ the Office of Pharmaceutical Quality Research (OPQR) to ensure quality, safety and efficacy of pharmaceutical products. In particular, this in vitro system will offer the capability for investigating the release performance of subcutaneous formulations under simulated physiological conditions. It assesses the critical drug attributes, risk and performance of subcutaneously administered drugs including biologics, peptides and small molecules.
Documents:

SSN_CDER-2025-126738_FINAL.pdf

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Biorelevant characterization system for subcutaneous injections - USA Tender

The HEALTH AND HUMAN SERVICES, DEPARTMENT OF | FOOD AND DRUG ADMINISTRATION, a Government sector organization in USA, has announced a new tender for Biorelevant characterization system for subcutaneous injections. This tender is published on USARFP under UST Ref No: 117369335 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2025-04-18.

The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.