Our Story
Who We Are
FDA Registration Assistance is a specialized regulatory consulting firm dedicated to helping businesses worldwide achieve and maintain FDA compliance. Founded by experts with deep knowledge of FDA regulations, we have grown to serve over 1,000 clients across 135+ countries.
Our team of experienced regulatory consultants understands the complexities of FDA requirements and the unique challenges that international manufacturers, exporters, and importers face. We provide clear, accurate, and cost-effective solutions that help our clients succeed in the U.S. market.
With over 15 years of experience, we have built a reputation for excellence in FDA registration, renewal, and compliance services — always putting accuracy and client success first.
Our Mission & Values
Why Clients Choose Us We are committed to providing expert FDA regulatory guidance that helps global businesses succeed in the U.S. market — with accuracy, speed, and full transparency at every step.- Deep Regulatory Expertise Specialists across all FDA-regulated categories — food, drugs, devices, cosmetics & supplements.
- 24–48 Hour Turnaround Fast, accurate submissions with complete documentation — no unnecessary delays.
- Truly Global Reach Serving clients in 135+ countries with deep knowledge of foreign manufacturer requirements.
- Dedicated Consultant One expert personally assigned to your account — consistent, accountable, and responsive.
- Cost-Effective Solutions Transparent pricing, no hidden fees — maximum compliance value for your investment.
- Long-Term Partnership From first registration to ongoing renewals — we stay with you through every compliance milestone.
About Us
Frequently Asked Questions
Everything you need to know about FDA Registration Assistance and how we help businesses achieve compliance worldwide.
FDA Registration Assistance is a specialized regulatory consulting firm dedicated to helping businesses worldwide achieve and maintain FDA compliance. Founded by experts with deep knowledge of FDA regulations, we have grown to serve over 1,000 clients across 135+ countries — providing accurate, fast, and cost-effective regulatory solutions tailored to your specific product category and market.
Our team has over 15 years of hands-on experience in FDA regulatory compliance. Since our founding in 2013, we have successfully guided more than 1,000 clients across 135+ countries through every aspect of FDA registration, renewal, and ongoing compliance requirements — from initial filing through to renewal and import alert resolution.
We serve businesses in food & beverage, dietary supplements, pharmaceuticals/drugs, medical devices, and cosmetics. Our expertise spans all major FDA-regulated product categories — from food facility registration under FSMA to cosmetic compliance under MoCRA to medical device 510(k) preparation and U.S. Agent services for foreign manufacturers.
Yes — the vast majority of our clients are international manufacturers, exporters, and importers. We work with companies from 135+ countries and have deep experience navigating the specific challenges that foreign businesses face when registering with the U.S. FDA, including mandatory U.S. Agent requirements and full import compliance obligations.
We combine 15+ years of FDA expertise with a client-first approach — meaning you receive accurate, personalized regulatory guidance rather than a one-size-fits-all service. Our team prepares complete, error-free submissions, delivers in 24–48 hours, and provides ongoing support so you stay compliant through renewals and regulatory changes.
Absolutely. Beyond initial registration, we offer annual renewal management, regulatory update alerts, U.S. Agent services, import alert assistance, and full compliance monitoring. Think of us as your outsourced FDA compliance department — always up-to-date, always responsive, and dedicated to keeping your business export-ready.
Getting started is simple. Contact us via phone at +1 (928) 275-8333, email us at [email protected], or use the contact form on our website. We'll schedule a free initial consultation, identify exactly which FDA registrations apply to your products, and provide a clear timeline and quote — with no obligation.
Get Started Today
Ready to GetFDA Compliant? Join over 1,000 clients worldwide who trust FDA Registration Assistance for accurate, fast, and fully compliant FDA registrations — backed by 15+ years of expertise and a team dedicated to your success.