What contracts does FDA Office Of Regulatory Affairs award?

FDA Office Of Regulatory Affairs awards government contracts across various categories. Browse contract opportunities from this agency.

How do I do business with FDA Office Of Regulatory Affairs?

To do business with FDA Office Of Regulatory Affairs, start by registering in SAM.gov and obtaining a UEI number. Then search for contract opportunities from this agency on CLEATUS. Review the agency's procurement history, identify relevant NAICS codes, and prepare competitive proposals. The contractors tab shows companies that have won contracts from this agency.

Who are the top contractors for FDA Office Of Regulatory Affairs?

View the full list of contractors who have won awards from FDA Office Of Regulatory Affairs in the contractors tab . You can filter by contract value, NAICS code, and set-aside type to find relevant competitors and potential teaming partners.

What set-aside programs does FDA Office Of Regulatory Affairs use?

FDA Office Of Regulatory Affairs uses 2 different set-aside programs, including Total Small Business Set-Aside (FAR 19.5) and Women-Owned Small Business. These programs reserve a portion of contracts for qualifying businesses. View the set-aside breakdown on the agency overview.

What does FDA Office Of Regulatory Affairs do?

The FDA Office of Regulatory Affairs advances public health by ensuring the safety, efficacy, and quality of regulated products through science-driven oversight and enforcement. Its core mission centers on supporting regulatory decision-making with advanced analytical capabilities, diagnostic tools, and forensic capabilities. Strategic priorities include modernizing laboratory infrastructure, enhancing product surveillance systems, and strengthening compliance monitoring—particularly in areas such as medical devices, in-vitro diagnostics, and forensic testing. The agency actively invests in technologies that enable real-time product tracking, laboratory accreditation, and international regulatory alignment, with a focus on securing the integrity of the U.S. food, drug, and medical device supply chains. Procurement patterns reveal a strong reliance on high-precision analytical instrumentation, specialized diagnostic substances, and technical services that support regulatory science. The agency frequently seeks laboratory equipment, software for monitoring regulated products, and consulting services to enhance operational efficiency and compliance workflows. Contract structures typically include sole-source, brand-name-or-equal, and combined solicitation vehicles, often leveraging government-wide acquisition contracts and indefinite-delivery/indefinite-quantity mechanisms to ensure rapid deployment of mission-critical capabilities. Industry preferences are dominated by manufacturers of analytical laboratory instruments and in-vitro diagnostic substances, alongside providers of computer systems design, professional scientific services, and specialized training. The agency demonstrates a clear preference for Small Business Administration set-asides, particularly for software licensing, forensic services, and technical consulting, while also occasionally targeting Women-Owned Small Business contracts for human resources and language support services. Vendor relationships are built on technical expertise, regulatory familiarity, and proven compliance with federal quality standards. Organized under the Food and Drug Administration within the Department of Health and Human Services, the Office of Regulatory Affairs operates nationwide with a decentralized field presence supporting inspections, investigations, and compliance activities. It employs a mix of direct procurement, interagency agreements, and cooperative contracts to fulfill its regulatory enforcement mandate across diverse geographic and scientific domains.

How do I find contracts from FDA Office Of Regulatory Affairs?

You can find contracts from FDA Office Of Regulatory Affairs on CLEATUS by visiting the agency's contracts tab. Search and filter by contract type, NAICS code, set-aside, and more. CLEATUS aggregates data from SAM.gov, FPDS, USASpending.gov, and state procurement systems.

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Federal Agency· 75DLLR

FDA Office Of Regulatory Affairs

Part of Department Of Health And Human Services

The FDA Office of Regulatory Affairs advances public health by ensuring the safety, efficacy, and quality of regulated products through science-driven oversight and enforcement. Its core mission centers on supporting regulatory decision-making with advanced analytical capabilities, diagnostic tools, and forensic capabilities.

FDA Office Of Regulatory Affairs

Part of Department Of Health And Human Services

Recent FDA Office Of Regulatory Affairs Contracts

NTELX Perpetual License, Software Maintenance & Support

NTELX Perpetual License, Software Maintenance & Support

Internet Monitoring Services of FDA Related Products

Internet Monitoring Services of FDA Related Products

3D Color Hand Scanner

FDA Office of Criminal Investigations (OCI) Human Resource Employment Consulting Services

FDA Forensic Testing Laboratory Accreditation

FDA National Dry Ice RFI

National Mammography Quality Surveillance Act (MQSA) Non-Federal Inspection State Contracts Program

Brand Name or Equal - Mango Foreign Languages Tools and Support

Search all FDA Office Of Regulatory Affairs contracts

Top FDA Office Of Regulatory Affairs Contractors

Search all FDA Office Of Regulatory Affairs contractors

Frequently Asked Questions

What does FDA Office Of Regulatory Affairs do?

What contracts does FDA Office Of Regulatory Affairs award?

How do I do business with FDA Office Of Regulatory Affairs?

Who are the top contractors for FDA Office Of Regulatory Affairs?

What set-aside programs does FDA Office Of Regulatory Affairs use?

Recently Posted by FDA Office Of Regulatory Affairs

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Recent FDA Office Of Regulatory Affairs Contracts

NTELX Perpetual License, Software Maintenance & Support

NTELX Perpetual License, Software Maintenance & Support

Internet Monitoring Services of FDA Related Products

Internet Monitoring Services of FDA Related Products

3D Color Hand Scanner

FDA Office of Criminal Investigations (OCI) Human Resource Employment Consulting Services

FDA Forensic Testing Laboratory Accreditation

FDA National Dry Ice RFI

National Mammography Quality Surveillance Act (MQSA) Non-Federal Inspection State Contracts Program

Brand Name or Equal - Mango Foreign Languages Tools and Support

Search all FDA Office Of Regulatory Affairs contracts

Top FDA Office Of Regulatory Affairs Contractors

Search all FDA Office Of Regulatory Affairs contractors

Frequently Asked Questions

What does FDA Office Of Regulatory Affairs do?

What contracts does FDA Office Of Regulatory Affairs award?

How do I do business with FDA Office Of Regulatory Affairs?

Who are the top contractors for FDA Office Of Regulatory Affairs?

What set-aside programs does FDA Office Of Regulatory Affairs use?