What types of technical services does the FDA Office of Regulatory Affairs prioritize?

ORA prioritizes services related to field inspection support, import surveillance, forensic laboratory analysis, and the maintenance of complex regulatory data systems used to track compliance across the food and drug sectors.

Are there specific certifications that help vendors win ORA contracts?

Vendors with specialized ISO certifications for laboratory operations or those demonstrating deep expertise in FDA regulatory frameworks and 21 CFR compliance are highly competitive for ORA task orders.

How does ORA typically structure its procurement for inspection and enforcement support?

ORA often utilizes task orders under existing HHS or FDA-wide IDIQ vehicles, focusing on vendors who can provide rapid deployment of technical personnel to support field offices and national laboratory networks during enforcement actions.

FOOD AND DRUG ADMINISTRATION · Contracting Office

FDA OFFICE OF REGULATORY AFFAIRS

5 solicitations and awards tracked for this contracting office.

Contracting office5 solicitationsUnder FOOD AND DRUG ADMINISTRATION

Solicitations

Federal records indexed

Source

Federal

Federal procurement data

Sub-Agency

FOOD AND

FOOD AND DRUG ADMINISTRATION

Agency

DEPARTMENT

DEPARTMENT OF HEALTH AND HUMAN SERVICES

About

Acquisition authority and contracting profile of FDA OFFICE OF REGULATORY AFFAIRS.

The FDA Office of Regulatory Affairs (ORA) procures specialized technical expertise to support field operations, import oversight, and laboratory analysis. Vendors compete for contracts involving scientific equipment, regulatory compliance software, forensic laboratory support, and investigative training services to maintain the integrity of the nation's food and drug supply.

Hierarchy: FOOD AND DRUG ADMINISTRATION · DEPARTMENT OF HEALTH AND HUMAN SERVICES.

Contracting officers at this office issue solicitations under the Federal Acquisition Regulation (FAR). Vendors must be registered in the federal procurement system with a valid CAGE code to receive awards.

Opportunity activity heatmap (2024-present)

Monthly posted opportunity volume from 2024 onward. Darker = more indexed records.

Count-basedPeak month: 32024-2026

2024

2025

2026

This view uses monthly opportunity counts from the public dataset. Monthly obligation dollars are not available on these pages.

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FDA OFFICE OF REGULATORY AFFAIRS contracting FAQ

Common questions about FDA OFFICE OF REGULATORY AFFAIRS, the parent hierarchy, and how vendors should track this contracting office.