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

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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"

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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."

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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"

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.

Food

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Drugs

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Medical Devices

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Cosmetics

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Since 2013, FDA Registration Assistance has specialized in helping businesses navigate the complexities of FDA compliance. Backed by over 15 years of industry experience, our team provides reliable and cost-effective solutions for FDA registration, renewal, and ongoing support. We are proud that clients return to us year after year, a testament to the trust and results we deliver. Our mission is simple: to make FDA compliance seamless so you can confidently grow in the U.S. market.

ATTITUDE

We Are Not Happy Until You Succeed

WE DELIVER

Fast & Reliable Service

WE CARE

Our Customers Are Our Top Priority

OUR TEAM

Over 15 Years Of Experience

COMPETING

Best Pricing in the Industry

Countries

We have clients in over 42 countries and we have offices in 3 of those countries.

Clients

Our clientele is growing everyday and we hope to have your company become part of the growing list.

Satisfaction

1 %

Our companies mission is to achieve 100% SATISFACTION with every client.

Pricing List

Santa Helena Co.

FDA Registration Assistance helped us overcome all our FDA concerns in a timely and cost effective manner. We will definetely use them again!

-Roberto, Export Associate

FDA Registration Assistance Registration Fees

Our pricing is the best in the industry paired along with the best service. For Our Pricing List Please Click Below

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© 2013 – 2026 FDA Registration Assistance. All Rights Reserved. FDA Registration Assistance is a private FDA regulatory consulting firm and is not the FDA.

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© 2013 – 2026 FDA Registration Assistance. All Rights Reserved. FDA Registration Assistance is a private FDA regulatory consulting firm and is not the FDA.