Orionex Regulatory Solutions

Orionex Trading LLC
Verified

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

### Why Global Exporters Choose Orionex<br><br>We are not a mailbox service. Orionex is a full-time, physically U.S.-incorporated regulatory firm dedicated exclusively to helping foreign manufacturers register with the FDA and maintain compliance.<br><br>**Key Features:**<br>* **Physically U.S. Incorporated:** Based in Casper, Wyoming USA — not a virtual address or P.O. box. Fully compliant with 21 CFR U.S. Agent physical presence requirements.<br>* **All 4 FDA Product Categories:** We cover food & supplements, medical devices, pharmaceuticals, and MoCRA cosmetics.<br>* **24-Hour Emergency Response:** Our emergency response protocol ensures critical notices like FDA import alerts and Warning Letters never go unanswered.<br>* **Certificate of Registration Included:** Every service includes your official Certificate of Registration.<br>* **Transparent Fixed Pricing:** The price you see is the price you pay. No hidden fees for standard communications or routine renewals.<br>* **Global Reach, Local Expertise:** We have active clients across 60+ countries and understand your market.

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

  • Physically incorporated in Wyoming, USA
  • Serves all 4 FDA product categories: food, devices, drugs, cosmetics
  • 24-hour emergency response for import alerts and Warning Letters
  • Transparent, fixed annual pricing
  • 15+ years of experience
  • Serves 1,200+ clients from over 60 countries

Certifications & Trust Signals

  • 1,200+ clients served
  • Clients in 60+ countries
  • 15+ years of experience
  • 98% FDA acceptance rate
  • Physically incorporated in the USA (Wyoming)

Buyer Snapshot

Best for
  • Foreign manufacturers exporting to the US
  • Companies needing FDA registration for food, devices, drugs, or cosmetics
  • Exporters seeking a compliant U.S. Agent with a physical presence
How engagement typically works
  • Full-service registration support
  • Annual representation
  • Emergency regulatory contact
Typical deliverables
  • FDA Establishment Registration
  • U.S. Agent Designation
  • Certificate of Registration
  • FDA FEI Number
  • NDC Labeler Code Assignment
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
Public email: info@orionexregulatory.com
Phone: +13074418160
Languages: English
Timezones: GMT
Access: Verified
Claim status: Claimed

Services & Capabilities

Best 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

Additional us_agent_fda Details

Product Types
food, devices, drugs, cosmetics
Registration Support
Yes
Emergency Contact24x7
No
US Entity State
Wyoming
Onboarding Steps
Select services, add to cart, complete order. Work begins within one business day. Regulatory team contacts client within one business day to collect information.
Request a Quote
⚡ Instant booking available
Appoint a Vetted FDA U.S. Agent in 2 Minutes
Compare Orionex Regulatory Solutions and other vetted providers — instant pricing, no RFQ needed.
Book now — instant pricing →
Cruxi - Regulatory Compliance Services