DM: Prediction Model Software
Type: Special Notice
Overview

Buyer

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

PSC

IT AND TELECOM - BUSINESS APPLICATION/APPLICATION DEVELOPMENT SUPPORT SERVICES (LABOR) (DA01)

Original Source

https://sam.gov/opp/58881d17a65d4a23b65220b2e4dc87b3/view
Timeline
    Description

    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking advanced prediction model software to enhance product quality and efficiency within its Division of Product Quality and Research (DPQR). The software must be capable of mining large and complex datasets to identify critical quality parameters and optimize product performance at a molecular level, particularly in a high-performance computing (HPC) environment. This procurement is vital for addressing product quality issues in pharmaceutical manufacturing and ensuring compliance with FDA standards. Interested vendors should contact Allison Meads at allison.meads@fda.hhs.gov or Steven Gagnon at steven.gagnon@fda.hhs.gov for further details, as the contract will follow a firm fixed price model with specific deliverables and a performance period extending until installation and warranty completion.

    Point(s) of Contact
    Allison Meads
    allison.meads@fda.hhs.gov
    Steven Gagnon
    steven.gagnon@fda.hhs.gov
    Files
    Title
    Posted
    SOL_Aspen_Unscrambler.docx
    The Office of Pharmaceutical Quality and Research (OPQR) is seeking advanced software for building predictive models to assess product performance in its digital twin platform, operating within a high-performance computing (HPC) environment. This software is essential for conducting multivariate data analysis, particularly for pharmaceutical manufacturing, addressing product quality issues using large datasets quickly and accurately. It must support real-time data analysis and flexible deployment of process analytical technology (PAT) methods. Key requirements include the capability to import various data formats, perform online and offline analyses, and ensure compliance with FDA quality standards. Additionally, the software should enable the identification of critical parameters related to quality and key performance indicators, enhancing product optimization at a molecular level. The contract will follow a firm fixed price model, with a performance period extending until the software installation and a one-year warranty are complete. All software and installation costs will be covered by the vendor, who must also ensure that the solution meets accessibility standards and is deployable in the FDA's laser-optimized HPC cluster. The document outlines specific deliverables, responsibilities of government contacts, invoicing instructions, and compliance with regulatory standards, emphasizing the need for reliable technology to underpin essential scientific work.
    Lifecycle
    Title
    Type
    DM: Prediction Model Software
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