What services does FDA Registration Assistance provide?

FDA Registration Assistance provides FDA compliance services including Food Facility Registration, FSVP support, U.S. Agent services, Drug Establishment Registration, Medical Device Registration and Listing, MoCRA cosmetic registration, labeling reviews, and import compliance guidance.

Do I need FDA registration to sell products in the United States?

Many FDA-regulated products require facility registration, product listing, or compliance steps before being sold or imported into the United States. Requirements depend on whether the product is food, supplements, cosmetics, drugs, or medical devices.

Do foreign companies need a U.S. Agent?

Yes. Many foreign FDA-regulated facilities must designate a U.S. Agent to communicate with FDA and support registration requirements.

How long does FDA registration take?

Timelines vary by product category and information readiness, but most FDA registrations and listings can be completed quickly once required details are provided.

Can you help with FDA shipment holds or compliance issues?

Yes. FDA Registration Assistance helps review FDA notices, correct compliance gaps, and guide next steps to prevent future shipment delays.

Trusted FDA Compliance and Registration Services for You

Registrations Made Easy

The Experts in FDA Regulatory Matter

The Experts in FDA Regulatory Compliance

FDA Registration Assistance is a leading consulting firm that provides FDA regulatory compliance solutions to the Food, Drug, Medical Device and Cosmetic industries. Our team of consultants provide expert guidance for all of your needs. To get started please click "Learn More"

fda regulatory compliance

MoCRA (Modernization of Cosmetics Regulation Act)

FDA Registration Assistance is here to help with the new FDA Cosmetic Regulations. We are here to simplify the process for you so you can continue creating opportunities for your company. To get started, please click "Learn More."

MoCra cosmetics registration

Food Facility Registration

Need a Food Facility Registration?

Food Facility Registration
$429

Food Facility Registrations are required to import any Food or Beverage into the United States. We help you through the whole process as well as provide U.S Agent Services. Do not wait any longer to register your food facility. For more information click "Register Now"

Food Facility Registration

Hand Sanitizer Registration

Need Help Registering your hand sanitizer?

Hand Sanitizer Registration

We can help you register your hand sanitizer with a fast / hassle-free process. Click "Register Now" for more information.

At FDA Registration Assistance, we provide complete FDA compliance and registration services for businesses in the food, medical device, pharmaceutical, cosmetic, dietary supplement, and import/export industries. Since 2013, we’ve helped over 700 clients across more than 75 countries navigate requirements set by the U.S. Food and Drug Administration — handling everything from FDA facility registrations and product listings to U.S. Agent services, FSVP compliance, label reviews, and ongoing regulatory consulting. Our goal is to remove the confusion, prevent costly mistakes, and ensure your business stays fully compliant at every stage.

Whether you’re launching a new product, importing into the U.S., or managing renewals and inspections, we act as your long-term FDA compliance partner — not just a form-filing service. We make the process fast, accurate, and stress-free while keeping your operations protected and market-ready. To explore each service in detail and see how we can support your specific industry, visit our full services page to learn more.