Orionex Regulatory Solutions
Orionex Trading LLC
A dedicated FDA regulatory consulting firm helping exporters worldwide with food, device, drug, and cosmetics compliance. Services include FDA registration and U.S. Agent representation.
Orionex Regulatory Solutions is a dedicated FDA regulatory consulting firm physically incorporated in Casper, Wyoming USA. We serve as FDA U.S. Agent for 1,200+ clients in 60+ countries across food, medical devices, drugs, and cosmetics. Transparent fixed pricing from $300/year. 98% first-round FDA acceptance rate. Official Certificate of Registration included with every service. Work begins within 1 business day.
About
**Who they are**
Orionex Regulatory Solutions is a dedicated FDA regulatory consulting firm assisting exporters globally with compliance for food, devices, drugs, and cosmetics. They specialize in FDA registration and U.S. Agent representation.
**Expertise & scope**
* FDA registration and U.S. Agent representation for food, devices, drugs, and cosmetics.
* Services include FDA registration and U.S. Agent representation.
* Operates within the US market.
* Supports exporters worldwide.
**Reputation / proof points**
* Based in Casper, Wyoming, serving the world.
* Responds to inquiries within one business day, with urgent matters addressed within four hours.
Orionex Regulatory Solutions is a dedicated FDA regulatory consulting firm assisting exporters globally with compliance for food, devices, drugs, and cosmetics. They specialize in FDA registration and U.S. Agent representation.
**Expertise & scope**
* FDA registration and U.S. Agent representation for food, devices, drugs, and cosmetics.
* Services include FDA registration and U.S. Agent representation.
* Operates within the US market.
* Supports exporters worldwide.
**Reputation / proof points**
* Based in Casper, Wyoming, serving the world.
* Responds to inquiries within one business day, with urgent matters addressed within four hours.
Additional information
Orionex Regulatory Solutions offers upfront pricing for all services, allowing clients to select needed services, add them to a cart, and complete their order securely via Stripe or PayPal. Work commences within one business day of order confirmation. The regulatory team will contact clients within one business day to gather necessary information. They provide a free initial consultation for those with questions or specific needs, such as first-time registrations, import alerts, or new product launches. Their specialists are available Monday through Friday.
Key Highlights
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Specializes in FDA registration and U.S. Agent representation.
Source
“Services include FDA registration and U.S. Agent representation.”
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Supports compliance for food, devices, drugs, and cosmetics.
Source
“helping exporters worldwide with food, device, drug, and cosmetics compliance.”
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Provides upfront pricing for all services.
Source
“Upfront pricing for every service.”
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Responds to inquiries within one business day.
Source
“Our FDA regulatory specialists respond to all inquiries within one business day”
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Offers urgent response within four hours for critical matters.
Source
“For urgent matters such as import detentions or Warning Letters, we typically respond within hours.”
Certifications & Trust Signals
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Based in Casper, Wyoming, serving the world.
Source
“Based in Casper, Wyoming —Serving the World”
Buyer Snapshot
Best for
- Exporters needing FDA registration and U.S. Agent representation.
- Companies in the food, device, drug, and cosmetics industries.
How engagement typically works
- Select services online and add to cart.
- Secure payment via Stripe or PayPal.
- Work begins within one business day.
Typical deliverables
- FDA Registration
- U.S. Agent Representation
Good to know
- Best when requiring FDA compliance for food, devices, drugs, or cosmetics.
Pricing
Model:
Onboarding + annual retainer
Facts
Examples & Achievements
With over 15 years of experience, Orionex has successfully served more than 1,200 clients from 60+ countries, maintaining a 98% FDA acceptance rate for registrations.
More about our services
Our services cover all four FDA product categories: food facilities (Bioterrorism Act), medical device establishments (21 CFR Part 807), drug establishments (CDER), and cosmetics (MoCRA). Each package includes U.S. Agent designation, complete registration filing, and an official Certificate of Registration. We also offer support for FCE/SID, Certificates to Foreign Government (CFS), label reviews, and GUDID/UDI submissions.
HQ:
Casper, USA
Languages:
English
Timezones:
GMT
Claim status:
Claimed
Services & Capabilities
Find FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
IN, CN, LK, VN, JP, KR, MY, TW, AU, PK, AE, SA, IL, EG, TR, DE, IT, FR, ES, NL, GB, PL, BE, SE, CA, MX, BR, CO, and 60+ countries worldwide, Switzerland, United Kingdom, Canada, Germany, France, Belgium, Italy, Spain, Denmark
Industries:
Food & Beverage, Medical Devices, Pharmaceuticals, Cosmetics, Dietary Supplements
Portfolio:
100+, 1-5, 6-25, 26-100
Flags:
high_portfolio, multi_country_coverage, fast_onboarding
Response SLA:
24 hours
Onboarding time:
1–3 days
Pricing model:
Onboarding + annual retainer
Starting from:
USD 300
Included services:
FDA facility registration, U.S. Agent designation, FDA communications handling, Certificate of Registration, Establishment registration support, Product listing assistance, Annual renewal reminders, Annual renewal support, 24/7 emergency response, Inspection coordination support
Product Type:
devices, food, drugs, cosmetics
Annual Renewal Support:
Yes
Registration Support:
Yes
Recall Support:
Yes
Time Zone Coverage:
US Mountain
Inspection Support:
Yes
Emergency Contact24x7:
Yes
Annual Renewal Reminder:
Yes
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