Orionex Regulatory Solutions — FDA Registration & U.S. Agent Services
Orionex Regulatory Solutions, a division of Orionex Trading LLC, is a U.S.-based FDA regulatory consulting firm headquartered in Casper, Wyoming. With over 15 years of experience, we specialize in helping manufacturers and exporters worldwide achieve full compliance with U.S. Food and Drug Administration requirements. Our services span FDA facility registration, U.S. Agent designation, product listing, label review, and regulatory consulting across all major product categories — including food and dietary supplements, medical devices, pharmaceutical drugs, and cosmetics (MoCRA).
As a licensed and designated U.S. Agent under FDA regulations, Orionex serves as the official point of contact between foreign facilities and the FDA. We manage all regulatory correspondence, renewal deadlines, and compliance updates on behalf of our clients — ensuring uninterrupted market access to the United States. Our team brings deep expertise across CDER, CDRH, CFSAN, and beyond, with a 98% first-round FDA acceptance rate that reflects our commitment to precision and thoroughness in every submission.
Trusted by clients in over 50 countries, Orionex is built on a foundation of transparency, integrity, and speed. We offer upfront, all-inclusive pricing with no hidden fees, and our regulatory team begins work within one business day of order confirmation. Whether you are registering with the FDA for the first time or managing ongoing compliance obligations, Orionex delivers expert guidance, fast turnaround, and a dedicated account manager — every step of the way.
FDA Registration Services for Seafood Export Company
Business Consulting
Confidential
March 2026
5.0
Quality
5.0
Schedule
5.0
Cost
5.0
Willing to Refer
5.0
"Their turnaround time, communication, and low cost were impressive."
Mar 4, 2026
CEO, Seaborn Harvest Pvt Ltd
LHC Sandakirani
Food & Beverage
Negombo, Sri Lanka
1-10 Employees
Online Review
Orionex Regulatory Solutions provided FDA registration services for a seafood export company. The team provided a form to be filled out, and also the client's registration details once it was completed.
Orionex Regulatory Solutions delivered a reasonable turnaround time and charged a low cost compared to their competitors, which was impressive for the client. The team communicated well via email and messaging apps. The client was impressed with Orionex Regulatory Solutions' turnaround.
BACKGROUND
Introduce your business and what you do there.
I’m the CEO of a seafood export company.
OPPORTUNITY / CHALLENGE
What specific goals or objectives did you hire Orionex Regulatory Solutions to accomplish for your seafood export business?
We needed help with FDA registration.
SOLUTION
What was the scope of their involvement?
Orionex Regulatory Solutions helped us with our FDA registration. I contacted them and asked for help with the registration. They asked me to fill out a form and make the payment. As soon as I made the payment, they did the registration and sent me the details. I received a confirmation email from the FDA.
What is the team composition?
We only worked with an unknown number of teammates.
How did you come to work with Orionex Regulatory Solutions?
Someone referred Orionex Regulatory Solutions to me. Their pricing fit our budget.
What is the status of this engagement?
We worked together in March 2026.
RESULTS & FEEDBACK
What evidence can you share that demonstrates the impact of the engagement?
FDA registration is a must for all seafood companies. Without it, we can’t ship to the US. Orionex Regulatory Solutions charged me $299 for one year of registration and US agent service. Other companies charge $1,000+ and take 2–3 days to process. Orionex Regulatory Solutions’ charges and time are very reasonable. Saving $500–$600 is a big thing for a company in a country like Sri Lanka.
How did Orionex Regulatory Solutions perform from a project management standpoint?
They were faster than I expected. We communicated via email and messaging apps.
What did you find most impressive about them?
Their turnaround time, communication, and low cost were impressive.
Are there any areas they could improve?
No, there aren’t any.
RATINGS
5.0
Quality
5.0
Service & Deliverables
Schedule
5.0
On time / deadlines
Cost
5.0
Value / within estimates
Willing to Refer
5.0
NPS
Showing 1-1 of
1 Reviews
Locations (1)
5830 East 2nd Street, Ste 7000 #23886Casper, WY,
United States82609
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