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Risk Model Contract

Active

Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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The Food and Drug Administration requires contractor support to update and maintain a risk-based site selection tool used for the surveillance inspection of outsourcing facilities and compounders. The selected contractor will provide technical support, functional enhancements, and continuous software upgrades to ensure the tool accurately ranks firms for inspection based on a multi-attribute risk management model. The contractor must possess specialized expertise in risk analysis, operations research, modeling, and mathematical methods to implement and evaluate the application software. This effort falls under NAICS code 541519 and is managed by the FDA's Center for Drug Evaluation and Research to ensure the risk-based inspection schedule remains efficient and data-driven.

General Info

FDA contractor will update and maintain a risk-based site selection tool for inspections.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541519 - Other Computer Related Services

Place of Performance

USA

Set-Aside

NONE

Documents

0

No documents available

Documents will appear here when they are available.

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cder Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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FDA must inspect outsourcing facilities according to a risk-based schedule based on several factors. This tool provides a risk-based ranking of outsourcing facilities & compounders for surveillance inspections. OCQC needs contractor support to update and maintain the Compounding risk-based site selection tool. The contractor is to provide technical support, performance and functional enhancements to the software. The contractor's expertise is risk analysis, operations research, modeling, and other relevant mathematical methods, to support, implement, and evaluate multi-attribute risk management model and application software that will support risk-based inspections from the existing tool. The tool requires continuous upgrades and data updates in order to accurately and efficiently rank firms for inspection.

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