What We Do at FDA Registration Assistance
Trusted by 1,000+ companies across 135+ countries, with 15+ years of FDA regulatory experience, based in Miami, Florida. Below: our core services, who we help, and how we work.
What We Handle
Food Facility Registration
Registering U.S. and foreign food facilities, with DUNS guidance, biennial renewals, ownership updates, and U.S. Agent service.
FSVP & Import Compliance
Acting as FSVP Agent, building and managing the program, supplier verification, and FDA inspection support for importers.
Medical Device Registration & Listing
Establishment registration, device listing, U.S. Agent service, 510(k)-exempt guidance, and annual renewals.
Drug Establishment Registration
Drug establishment registration, product listing, NDC labeler codes, annual renewals, and U.S. Agent service.
Cosmetics & MoCRA
Cosmetic facility registration, product listing, Responsible Person designation, U.S. Agent service, and ongoing compliance.
Running through all of it is U.S. Agent service for every FDA category — the required U.S. point of contact for foreign food, drug, device, and cosmetic facilities.
The Companies We Work With
Our clients span the full range of FDA-regulated business — whether entering the U.S. market for the first time or managing ongoing compliance:
| By role | By category |
|---|---|
| Manufacturers & contract manufacturers | Food & beverage producers |
| Importers & exporters | Medical device companies |
| Amazon & e-commerce sellers | Pharmaceutical & OTC drug firms |
| Startups & global brands | Cosmetic brands & supplement businesses |
Our Compliance Process
What We Don't Claim
Tell Us What You're Bringing to the U.S. Market
Send us your company and product details, and we'll identify exactly which FDA registrations, listings, and programs apply — then handle them and stay on for renewals and ongoing support. Email info@fdaregistrationassistance.com or call +1 (928) 275-8333.
Frequently Asked Questions — What We Do
What does FDA Registration Assistance do?
We provide end-to-end FDA registration, U.S. Agent services, FSVP programs, product listing, label review, and ongoing compliance support across food, drugs, medical devices, cosmetics, and dietary supplements for U.S. and foreign companies.
Which product categories do you cover?
All four FDA-regulated categories plus supplements: food and beverage, pharmaceuticals and OTC drugs, medical devices, cosmetics under MoCRA, and dietary supplements. Many clients have products in more than one category.
Do you work with international companies?
Yes. A large share of our clients are foreign manufacturers and exporters across 135+ countries, and we specialize in foreign facility registration and U.S. Agent representation for the U.S. market.
Can you act as our U.S. Agent?
Yes. We serve as the U.S. Agent for foreign food, drug, medical device, and cosmetic facilities, acting as the FDA's U.S. point of contact for communications and inspection coordination.
Do you handle FSVP for importers?
Yes. We act as FSVP Agent and build and manage Foreign Supplier Verification Program plans — hazard analysis, supplier verification, and recordkeeping — so imported food clears without FSVP-related holds.
Is FDA registration mandatory to sell in the U.S.?
For most food, drug, device, cosmetic, and supplement companies, yes. Facilities generally must register and list products before legally selling, and failing to do so can lead to refusals, holds, and enforcement.
Does registration mean my product is FDA approved?
No. Facility registration places you in the FDA's system as required by law; it is not approval or endorsement. Drug approval and device 510(k) clearance are separate processes from establishment registration.
Do you handle renewals and ongoing compliance?
Yes. We track deadlines and manage renewals, updates, and ongoing support — food and cosmetic facility registrations renew biennially, while drug and device establishment registrations renew annually.
How long does registration take?
Once the required information is provided, most facility registrations are completed within a few business days. Specialized filings, premarket submissions, and process filings take longer to prepare.
Are you affiliated with the FDA?
No. We are an independent compliance consulting firm. We work directly with FDA systems and regulations to help businesses register and stay compliant, but we are not part of or endorsed by the FDA.
Do startups and small businesses need FDA registration?
Yes. FDA requirements apply regardless of company size. Startups, Amazon sellers, and global manufacturers alike generally must register facilities and list products before selling regulated goods.
Do you work with Amazon and e-commerce sellers?
Yes. We regularly support Amazon FBA sellers and online brands with registration, FSVP, U.S. Agent service, and label review, since marketplaces often request proof of FDA compliance.
What happens if my business isn't FDA compliant?
Non-compliance can lead to import detentions, refusals, recalls, warning letters, penalties, and loss of marketplace or retailer approval. We help prevent these by getting compliance right from the start.
Can you help if a shipment is being held?
Yes. We assist with compliance corrections, documentation, and FDA communication to help resolve shipment holds and refusals as efficiently as the situation allows.
What information do you need to start?
Typically your company and facility details, product categories, manufacturing or sourcing information, and responsible contacts. We guide you step by step so the process stays clear and manageable.
Do you review product labels?
Yes. We review food, supplement, drug, device, and cosmetic labels for FDA compliance — claims, formatting, allergens, and required disclosures — to help avoid misbranding and costly relabeling.
Do you provide consulting beyond registration?
Yes. We offer regulatory strategy, compliance review, label review, FSVP management, inspection preparation, and ongoing consulting, acting as a long-term compliance partner rather than a one-time filer.
Do you handle medical device registration and listing?
Yes. We support device establishment registration, device listing, U.S. Agent service, 510(k)-exempt guidance, and annual renewals, and can flag where a premarket submission is needed.
Do you handle drug establishment registration?
Yes. For pharmaceutical and OTC drug companies we handle drug establishment registration, product listing, NDC labeler codes, annual renewals, and U.S. Agent service.
Do you handle cosmetic and MoCRA compliance?
Yes. Under MoCRA we handle cosmetic facility registration, product listing, Responsible Person designation, U.S. Agent service, and ongoing compliance support.
Will you remind me when renewals are due?
Yes. We track renewal and update deadlines and notify you in advance so your registrations stay active and you don't face a lapse that blocks shipments at the border.
Why use you instead of registering myself?
Registrations can be filed directly, but errors are common and can cause holds, refusals, or compliance problems. We aim to get filings right the first time and provide ongoing support, deadline tracking, and guidance.
Where are you based?
We are a U.S.-based FDA compliance consulting firm headquartered in Miami, Florida, which lets us serve as a U.S. Agent and work within the U.S. regulatory environment for clients worldwide.
How much do your services cost?
Fees depend on the product category and scope of work. We provide clear quotes tied to your specific registrations and services. Contact us with your products and facility details for pricing.
How do I get started?
Send us your company and product details and what you're bringing to the U.S. market. Contact our team and we'll identify exactly which FDA registrations and programs apply. Email info@fdaregistrationassistance.com or call +1 (928) 275-8333.
