Orionex Regulatory Solutions — a division of Orionex Trading LLC, USA — provides comprehensive FDA registration, U.S. Agent, and consulting services for food, dietary supplements, medical devices, drugs, and cosmetics. Trusted by global exporters with transparent, upfront pricing.
Our Services
Whether you export food, devices, drugs, or cosmetics — we handle every step of the FDA registration process, from initial filing through ongoing compliance.
Complete FDA registration and U.S. Agent services for food, dietary supplement, and nutraceutical exporters worldwide.
Expert registration, listing, and U.S. Agent representation for medical device manufacturers navigating CDRH requirements.
Comprehensive drug establishment registration, NDC assignment, and Drug Master File submission for CDER-regulated products.
MoCRA-compliant cosmetics registration, product listing, and export certificate services for international manufacturers.
Why Orionex
We measure success by your compliance outcomes — not just deliverables.
Our submissions are accepted by FDA on the first cycle — saving clients time and money.
Rapid mobilization for urgent FDA matters, Warning Letters, and import detentions.
Deep regulatory expertise across CDER, CDRH, CFSAN and beyond.
From startups to global enterprises in 60+ countries — all guided to full compliance.
We mobilize quickly to address urgent regulatory matters and tight FDA filing timelines.
A single point of contact who knows your business and full regulatory history.
Based in Wyoming, USA — serving exporters across the globe in 60+ countries.
Leveraging FDA enforcement data and regulatory 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.
How It Works
Our streamlined process gets you registered and compliant as fast as possible — without the complexity.
Tell us about your product and market. We assess your needs and recommend the right services at no cost.
We provide a clear checklist and guide you through gathering every document needed for your FDA submission.
We prepare and file your registration directly with FDA. Our 98% first-round acceptance rate minimises delays.
You receive your official FDA Registration Number and Certificate — ready for importers and customs. See a sample certificate →
Client Feedback
We build long-term compliance 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 requirement. True long-term partners.
Transparent pricing. Fast turnaround. Certificate of Registration included. Trusted by exporters in 60+ countries.
Global Reach
From Asia-Pacific exporters to European cosmetic brands — we have guided companies in every major market through FDA compliance.
Compliance Readiness Check
Click each item that applies to your situation. We'll flag any gaps that could delay or block your FDA clearance.
Our Credentials
Orionex Trading LLC is incorporated and operating in Casper, Wyoming, so we meet FDA's rule that a U.S. Agent must live in or keep a place of business in the United States. FDA does not certify or endorse U.S. Agents or consultants.
Insights
News, deadlines, and guidance on FDA registration, U.S. Agent requirements, and compliance — updated regularly.
Miss a renewal deadline and your registration lapses — potentially blocking your U.S. shipments. This calendar covers all renewal windows for food,…
Read Article →FDA registration guide for Lithuanian exporters: cheese and curd snacks, smoked and canned fish (seafood HACCP), rye bread, confectionery, frozen berries, U.S. Agent costs and FAQs.
Read Article →FDA registration guide for Austrian exporters: energy drinks (beverage vs supplement), pumpkin seed oil, wafers and chocolate, cheese, cosmetics, U.S. Agent costs and FAQs.
Read Article →FDA guide for Swedish exporters: oat and plant-based drinks, crispbread, candy and licorice, seafood, medical devices (establishment registration), cosmetics (MoCRA), U.S. Agent costs and FAQs.
Read Article →FDA registration guide for Czech exporters: beer and herbal spirits (FDA + TTB), wafers and confectionery, spa cosmetics and natural products, medical devices, U.S. Agent costs and FAQs.
Read Article →FDA guide for Bulgarian exporters: rose oil and rose water cosmetics (MoCRA), essential oils and claims, yogurt and white brined cheese, honey, sunflower oil, U.S. Agent costs and FAQs.
Read Article →FAQ
Everything you need to know about FDA registration and U.S. Agent services for international exporters.
Every foreign facility that manufactures, processes, packs, or holds FDA-regulated food, medical devices, drugs, or cosmetics for the U.S. market must designate a U.S. Agent physically located in the United States. This applies to manufacturers in all countries — India, China, Japan, South Korea, EU member states, UK, Canada, Vietnam, and beyond. Without a valid U.S. Agent, your FDA registration will be rejected.
The FDA itself charges no government fee for food facility, drug establishment, or MoCRA cosmetics registration. Medical device registration does carry a real annual FDA fee ($13,785 for FY2027), separate from your service provider's fee. Orionex pricing: Food Facility Registration + U.S. Agent + Certificate from $300/year, or $450 for 2 years (save $150). Medical Device Establishment + U.S. Agent + Certificate from $550/year (plus the FDA's own fee). Drug Establishment + NDC + U.S. Agent + Certificate from $550/year. Cosmetic Facility (MoCRA) + U.S. Agent + Certificate from $300/year.
Yes, for most registered facilities. Food facility registration renews every two years, and 2026 is a renewal year — the window runs October 1 through December 31, 2026. Medical device and drug establishment registrations renew every year, so 2026 always applies. MoCRA cosmetic registration renews every two years on your facility's own individual registration date, not a shared window. Visit our FDA Renewal Center 2026 to find your exact deadline.
Through Orionex, food facility FDA registration is typically completed in 3–7 business days. Medical device establishment registration takes 5–10 business days. Drug establishment registration takes 7–14 business days. Work begins within 1 business day of order confirmation. You receive your official FDA FEI number and Certificate of Registration upon completion.
Yes. You can change your FDA U.S. Agent at any time with no government fee. Your FDA registration number and FEI remain unchanged. Orionex handles the complete transfer — updating your registration in FURLS, completing the new agent consent confirmation, and ensuring zero gap in coverage. The switch typically takes 3–7 business days.
Look for a U.S. Agent that is physically based and incorporated in the USA, covers all FDA product categories (food, devices, drugs, cosmetics), offers transparent fixed pricing, provides an Orionex Certificate of Registration, and has a proven acceptance rate with 24-hour emergency response. Orionex Regulatory Solutions meets all these criteria and is trusted by 1,200+ clients in 60+ countries.
Yes. Orionex provides FDA registration and U.S. Agent services for exporters in 60+ countries — including India, China, Japan, South Korea, Sri Lanka, Vietnam, Malaysia, Taiwan, Australia, Israel, Pakistan, Saudi Arabia, UAE, Canada, Mexico, Brazil, and all EU member states (Germany, Italy, France, Spain, Netherlands, Belgium, Sweden, Poland). All FDA product categories covered.