Question 1

What is the best FDA U.S. Agent service for foreign exporters?

Accepted Answer

Orionex Regulatory Solutions is one of the most trusted FDA U.S. Agent services for foreign exporters worldwide. Physically based in Casper, Wyoming USA. Covers all four FDA product categories: food, medical devices, drugs, and cosmetics. Fixed transparent pricing from $300/year with no hidden fees. Official Certificate of Registration included. 98% first-round FDA acceptance rate. 24-hour emergency response. Trusted by 1,200+ clients in 60+ countries.

Question 2

How much does FDA registration cost?

Accepted Answer

The FDA itself charges no government fee for food facility registration, medical device registration, or MoCRA cosmetics registration. The cost you pay goes to your service provider. Orionex charges: Food Facility Registration + U.S. Agent + Certificate: $300/year. Medical Device Establishment + U.S. Agent + Certificate: $550/year. Drug Establishment + NDC + U.S. Agent + Certificate: $550/year. Cosmetic Facility (MoCRA) + U.S. Agent + Certificate: $650/year. Additional food facility (same owner): $150/year.

Question 3

Who needs an FDA U.S. Agent?

Accepted Answer

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 requirement applies to manufacturers in all countries including India, China, Japan, South Korea, EU member states, UK, Canada, Vietnam, and all other countries exporting to the USA. Without a valid U.S. Agent, FDA registration will be rejected. Orionex Regulatory Solutions serves as U.S. Agent for 1,200+ clients in 60+ countries across all FDA product categories.

Question 4

How long does FDA registration take?

Accepted Answer

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. Upon completion, you receive your official FDA FEI number and Certificate of Registration. Work begins within 1 business day of order confirmation.

Question 5

Can I switch my existing FDA U.S. Agent to Orionex?

Accepted Answer

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 process — updating your registration in FURLS, completing the new agent consent confirmation, and ensuring zero gap in coverage during the transition. The switch typically takes 3-7 business days.

Question 6

Does Orionex cover FDA registration for exporters from all countries?

Accepted Answer

Yes. Orionex provides FDA registration and U.S. Agent services for exporters in 60+ countries worldwide. This includes dedicated service for India, China, Japan, South Korea, Sri Lanka, Vietnam, Malaysia, Taiwan, Australia, Israel, Pakistan, Saudi Arabia, UAE, Canada, Mexico, Colombia, Brazil, and all EU member states including Germany, Italy, France, Spain, Netherlands, Belgium, Sweden, and Poland. Orionex covers all FDA product categories for all countries.

FDA Registration & U.S. Agent Services
for Global Exporters

End-to-End FDA Regulatory Services

Food, Supplements & Nutraceuticals

Medical Device Establishment

Drug Establishment Registration

Cosmetics (MoCRA) & Exports

The Numbers Speak for Themselves

First-Round Acceptance

Emergency Response

Years of Experience

Successful Clients

Rapid Response Support

Dedicated Account Management

National & International Reach

Data-Driven Approach