Complete FDA Compliance Services — One Trusted Partner
From initial registration to ongoing renewals — expert FDA regulatory consulting for food, drugs, medical devices, and cosmetics. Trusted by 1,000+ companies across 135+ countries since 2013.
What We Offer
End-to-End FDA Registration
& Compliance Solutions
We handle every aspect of FDA compliance — from first-time registration to biennial renewals, label reviews, import compliance, and ongoing regulatory strategy.
Accurate Filings
Zero-error FDA registration submissions — eliminating rejection risk and costly delays.
24–48 Hr Turnaround
Most FDA registrations confirmed within 24–48 hours of complete submission.
Ongoing Compliance
We track renewals, regulatory changes, and updates — keeping you import-ready year-round.
Global Reach
We serve companies in 135+ countries — handling FDA compliance from anywhere in the world.
Dedicated Consultants
A named regulatory consultant manages your account from start to finish.
U.S. Agent Services
Mandatory FDA point-of-contact for all foreign regulated manufacturers — we've got you covered.
Industries We Serve
FDA Registration Across Every Regulated Industry
Whether you manufacture food, pharmaceuticals, cosmetics, or medical devices — we have the expertise to handle your FDA compliance.
End-to-end FDA food compliance — from initial registration to biennial renewals, FSVP, and Prior Notice.
- Food Facility Registration & Renewals
- U.S. Agent & FSVP Agent Services
- FDA Prior Notice Submission
- Label & Ingredient Review
Pharmaceutical and OTC drug establishment registration, NDC listing, label compliance, and cGMP guidance.
- Drug Establishment Registration
- NDC & Drug Listing (FDA 2657)
- U.S. Agent Services
- Label Review & cGMP Guidance
MoCRA facility registration, product listings, label compliance reviews, and ongoing cosmetic compliance support.
- MoCRA Facility Registration
- Cosmetic Product Listing
- U.S. Agent Services
- Label & Claims Compliance
Medical device establishment registration, device listing, PMA support, QMS guidance, and annual renewals.
- Device Establishment Registration
- Device Listing & Classification
- U.S. Agent Services
- Annual Renewals & Post-Market
Specialized Services
Full-Spectrum FDA Compliance Support
Beyond core registrations — every FDA compliance service your business needs, under one roof.
U.S. Agent Services
FDA-required U.S. Agent for all foreign regulated manufacturers. Dedicated, responsive, and always available to FDA.
Learn moreFSVP Agent Services
Full FSVP compliance for U.S. importers — hazard analysis, supplier verification records, and ongoing program management.
Learn moreFDA Prior Notice
Accurate electronic Prior Notice submission for all food shipments to the U.S. — submitted before your cargo arrives at port.
Learn moreLabel & Ingredient Review
Expert label compliance review for food, drugs, devices, and cosmetics — preventing misbranding and adulteration violations.
Learn moreImport & Importer Compliance
Avoid import alerts, border holds, and refusal notices. Full FDA entry compliance and corrective action plans for U.S. importers.
Learn moreDietary Supplement Registration
FDA facility registration, NDI notifications, product listing, label compliance, and cGMP guidance for supplement manufacturers.
Learn moreRenewal Management
Never miss a renewal deadline. We proactively track and manage all FDA registration renewals — food, drug, device, and cosmetic.
Learn moreImport Alert Removal
Currently on FDA import alert? We create and submit corrective action plans (CAPs) to resolve detentions and restore your import status.
Get HelpFree Consultation
Not sure what FDA registrations your business needs? Get a free, no-obligation consultation with our regulatory experts — typically within 24 hrs.
Book Free ConsultWhy Choose Us
The #1 Rated FDA Registration Service Worldwide
Trusted by global manufacturers, brand owners, importers, and sponsors since 2013.
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Start Today — Free Consultation
Ready to Get FDA Compliant?
Join 1,000+ companies in 135+ countries who trust FDA Registration Assistance for accurate, fast, and cost-effective FDA compliance. Get started today — free consultation, no obligation.
Contact Us for a Free Consultation
Miami, FL 33160