FDA Registration & U.S. Agent
Initial registration, renewal, U.S. Agent, verification, Prior Notice and ongoing compliance for food, supplement, cosmetic and OTC facilities.
- Registration
- Renewal
- U.S. Agent
- Prior Notice
FDA Regulatory Compliance for U.S. Market Entry
FDA registration, U.S. Agent, GMP/cGMP, label review and import support for food, beverage, supplement, cosmetic and OTC manufacturers. Talk to a person before you fill out any form.
Request Information Prefer to talk? +52 33 1125 7553 WhatsApp
A Grupo Nativot Company · Est. 2012
Industries we serve
Each industry has its own FDA path. Start with yours.
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Food
Fresh, dried, canned, retort, ready-to-eat and pouch products.
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Beverages
Juices, nectars and shelf-stable drinks.
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Dietary Supplements
Multivitamins, minerals, capsules, gummies and powders.
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Cosmetics & Personal Care
Skin, hair and personal care, including antiseptics.
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OTC Products
Drug establishment registration, listing and Drug Facts labels.
GMP / cGMP We certify your facility for U.S. markets.
The Access FDA GMP Assessment & Certification Program takes your plant from gap assessment to certification-ready systems: SOPs, quality systems, training, internal audits and mock FDA inspections.
- Food · 21 CFR Part 117
- Dietary supplements · 21 CFR Part 111
- Cosmetics · FDA cosmetic GMP guidance
Our certificates are private documents based on a defined scope and methodology; they are not issued, approved or sponsored by FDA.
What we handle for you
From the first registration to the shipment at the border, with the same team.
Advanced Label Review
Upload your label. We review Nutrition or Supplement Facts, ingredients, allergens, claims and warnings for the U.S., with Mexico as an option.
Upload your labelOTC products
Antiseptics, sunscreens and other OTC drugs need drug establishment registration, product listing and a compliant Drug Facts label. We assess the classification first.
OTC supportOther FDA Services
Prior Notice, import regulatory support and regulatory consulting when your need does not fit a single box.
Beyond registrationWhat stage is your project in?
Pick the closest one. We will take you to the right place with your answer already filled in.
How we work
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Tell us about your project
By phone, WhatsApp or a short form.
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Regulatory assessment
We identify what applies to your product and facility.
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Scope and proposal
A clear scope and price before any work starts.
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Implementation
We prepare and submit with your team.
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Ongoing support
Renewals, updates and questions within your scope.
Why companies call Access FDA
Since December 2012
Access FDA is the regulatory services brand of Grupo Nativot, based in Guadalajara, Mexico.
About Access FDA-
A person on the line
Direct attention by phone, WhatsApp or Google Meet, in English or Spanish.
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Grounded in 21 CFR
Our work is based on the FDA regulations that apply to your product.
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Clear limits
We never promise FDA approval, a border release or results outside our control.
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Private and independent
A private consulting firm, not affiliated with FDA.
Prefer to Talk?
Speak directly with Access FDA by phone or WhatsApp.
Free Consultation on WhatsApp
Up to 10 minutes to understand your project, identify what you need and agree on next steps.
Need more time? Book a 60-minute Regulatory Consultation ($1,575 MXN / $90 USD), credited if you then contract FDA Establishment Registration.
Ready to take your products to the U.S.?
Tell us what you make and where you want to sell it.