Orionex Trading LLC

Global Trade &
Regulatory
Solutions

A Wyoming-registered holding company delivering specialized compliance, regulatory, and trade services to businesses entering the United States market.

FDA Registration Services Learn more
Orionex Regulatory Solutions
Active
Service CategoryFDA Registration
Markets ServedAsia · Africa · Europe
Turnaround3–7 Business Days
U.S. Agent ServiceIncluded
Registered in
Casper, Wyoming — USA
FDA Registered U.S. Agent
Wyoming Incorporated
Food · Drug · Device · Cosmetic
Fast 3–7 Day Turnaround
About Us

Built for businesses entering the U.S. market

Orionex Trading LLC is a Wyoming-registered holding company founded to support international businesses navigating U.S. market entry. Through our specialized subsidiaries, we deliver FDA registration, regulatory compliance, and trade advisory services to clients across Asia, Africa, and Europe.

50+
Countries Served
3–7
Day Turnaround
4
Product Categories
100%
Compliance Rate
"We bridge the regulatory gap between global manufacturers and the United States market — efficiently and reliably."
Orionex
Orionex Trading LLC
Casper, Wyoming — United States
Our Divisions

Specialized subsidiaries,
singular focus

Live & Active
Orionex Regulatory Solutions
FDA Registration · U.S. Agent Services
Full-service FDA registration and designated U.S. Agent representation for food, drug, device, and cosmetic manufacturers worldwide. Fast, compliant, and cost-effective market entry.
Visit orionexregulatory.com
3–7d
Avg. Turnaround
50+
Countries Served
4
Product Categories
100%
Compliance Rate
Food & Beverage Facility Registration
Drug Establishment Registration
Medical Device Registration & Listing
Cosmetic Facility Registration (MoCRA)
Prior Notice Filing & U.S. Agent Services
🌐
Coming Soon
Trade Advisory
Import · Export · Customs
Strategic guidance for U.S. import regulations, tariff classification, and cross-border trade logistics.
In Development
📋
Coming Soon
Compliance Group
Documentation · Labeling · Audit
End-to-end compliance documentation, product labeling review, and pre-market audit support.
In Development
🏭
Q3 2026
Supply Chain Solutions
Logistics · Sourcing · Fulfillment
U.S. supply chain management, warehouse partnerships, and last-mile fulfillment for importers.
Pipeline
🔬
Q4 2026
Lab & Testing Services
Testing · Certification · Analysis
Connecting global manufacturers with FDA-accredited U.S. laboratories for product testing and certification.
Pipeline
Services

What we do
exceptionally well

Every service is designed to reduce friction and accelerate your entry into the world's largest consumer market.

01
FDA Facility Registration
Register food, drug, device, and cosmetic facilities with the FDA. Mandatory for all foreign manufacturers shipping to the U.S.
02
U.S. Agent Services
We serve as your designated U.S. Agent — the FDA-required point of contact for all foreign registered facilities.
03
Prior Notice Filing
Mandatory FDA prior notice submissions for all food and beverage shipments entering the United States.
04
FSVP Compliance
Foreign Supplier Verification Program support ensuring your supply chain meets FDA's food safety requirements.
05
Device Registration & Listing
Medical device establishment registration and product listing with the FDA's Center for Devices and Radiological Health.
06
Labeling & Documentation
Review and preparation of product labels, declarations of conformity, and regulatory documentation packages.
Get Started with FDA Registration