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Orionex Regulatory Solutions provides comprehensive FDA registration, U.S. Agent, and consulting services for food, dietary supplements, medical devices, drugs, and cosmetics — with transparent, upfront pricing.
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We mobilize quickly to address urgent regulatory matters and tight filing timelines.
A single point of contact who knows your business and full regulatory history.
Based in Wyoming, serving clients across the U.S. and in global markets.
Leveraging FDA enforcement data and precedent to build the strongest submissions.
About Orionex
Orionex Regulatory Solutions, a division of Orionex Trading LLC, is a U.S.-based FDA consulting firm dedicated to helping businesses in food, dietary supplements, medical devices, drugs, and cosmetics achieve complete regulatory compliance.
We simplify FDA registration and provide expert guidance as your U.S. Agent, ensuring your products meet all U.S. regulatory requirements efficiently and confidently.
Our team brings deep expertise in FDA regulations, enforcement trends, and submission best practices — giving our clients a competitive advantage in a complex regulatory landscape.
Why Orionex
We measure success by your compliance outcomes — not just deliverables.
Our submissions are accepted by FDA on the first cycle at an industry-leading rate.
Rapid mobilization for urgent FDA matters, Warning Letters, and time-sensitive filings.
Deep regulatory expertise built over more than a decade of complex client engagements.
From startups to established enterprises — we've guided them all to compliance.
Client Feedback
We build long-term partnerships — not one-time transactions.
"Orionex helped us navigate a complex 510(k) submission that three other consultants said would take 18 months. They got it cleared in 11. Their knowledge of FDA requirements is unmatched."
"After receiving a Warning Letter, we were in crisis mode. Orionex stepped in within 24 hours, developed a comprehensive CAPA plan, and helped us restore our standing with FDA quickly."
"Their FSMA compliance program saved us months of internal work. The team is thorough, highly responsive, and explains the 'why' behind every regulatory requirement. True partners."
Get In Touch
Whether you're launching a new product, preparing a submission, or facing a compliance challenge — our team is ready to help.
5830 E 2nd St, Ste 7000
Casper, WY 82609
Monday – Friday: 8:00 AM – 6:00 PM MT