FDA Registration & U.S. Agent Services for Global Exporters. Orionex Regulatory Solutions — a division of Orionex Trading LLC, USA — reviews every submission and guides you through the entire process, from form completion to FDA approval.
Choose Your Form
Browse all FDA registration, listing, and label review forms. Not sure which applies? Contact us for guidance.
Required for all domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.
Open Form →Required for establishments that manufacture, distribute, or import medical devices sold in the United States, including Class I, II, and III devices.
Open Form →Required for all establishments that manufacture, repack, relabel, or salvage prescription drugs, OTC drugs, API, or finished pharmaceutical products.
Open Form →Required under MoCRA for all domestic and foreign facilities that manufacture or process cosmetic products for distribution in the United States.
Open Form →Required before marketing any drug product in the U.S. Lists product details, labeler info, active & inactive ingredients, packaging, and NDC codes.
Open Form →Required under MoCRA for responsible persons to list each cosmetic product with FDA, including all ingredients, product categories, and labeler details.
Open Form →Submit your food product label for expert review ensuring full compliance with FDA labeling requirements including nutrition facts, allergens, and claims.
Open Form →Submit your cosmetic product label for professional compliance review covering ingredient declaration, net quantity, identity statements, and MoCRA requirements.
Open Form →Submit your OTC or prescription drug product label for a thorough compliance review covering all FDA labeling requirements under 21 CFR Parts 201 and 330.
Open Form →How It Works
We handle the complexity so you can focus on your business.
Select the FDA registration form that matches your product type above.
Complete the online form with your facility and product details.
Our FDA specialists review your submission and contact you within 24–48 hours.
We file with FDA on your behalf and deliver your registration confirmation.