- Guided form collects your product data
- AI validates ingredient names against FDA nomenclature
- Specialists submit through FDA's Cosmetics Direct
- Updates and delisting included
MoCRA · FDA · 8 languages
The global compliance platform for cosmetics, drugs & medical devices.
AI-accelerated FDA compliance, verified by regulatory experts — your fastest path to the US market.
- US-based team
- Regulatory experts + AI
- Serving brands worldwide
Services
Everything you need to enter and stay in the US market
Every service combines AI-powered workflows with review by human regulatory specialists.
- Registration prepared and submitted for you
- Biennial renewals tracked and filed on time
- Continuous registration status monitoring
- Compliance dashboard shows where you stand
- We receive and relay all FDA communications
- Fast responses keep your registration valid
- Required for every non-US facility
- Simple flat annual fee
- Facility registration, product listing, and US Agent
- Label compliance and adverse-event readiness
- Safety substantiation guidance
- One annual program, one named specialist
- AI pre-screens artwork and ingredient lists
- Checked against 21 CFR 701, FPLA, and MoCRA
- A specialist confirms every finding
- Clear corrections report before you print
- US contact channel for consumer adverse events
- Structured intake, records, and triage
- Serious reports filed with FDA within 15 business days
- Establishment registration and product listing
- US Agent representation
- Labeling review for drugs and devices
- Consultative — talk to our specialists
How it works
- 1
Tell us about your products
A five-minute form is all we need to start your free assessment.
- 2
AI gap analysis, expert-reviewed
Our AI maps your products against FDA requirements; a regulatory specialist reviews every finding.
- 3
We file, represent, and monitor
Registrations, listings, and US Agent service handled — you sell in the US.
AI speed. Human accountability.
Our platform accelerates the work. Our specialists own the result.
What our AI does
- Pre-checks labels and ingredient lists against FDA rules in minutes
- Monitors registration status and deadlines around the clock
- Drafts filings in minutes, not weeks
What our experts do
- Review and sign off on every filing
- Handle all FDA communications
- Own the edge cases that need human judgment
Industries we serve
- CosmeticsAvailable now
- DrugsAvailable now
- Medical DevicesAvailable now
- Food & BeverageComing soon
Meeting us at Cosmoprof Las Vegas, July 13–15? Come talk compliance at our booth.
Book a booth chatFrequently asked questions
Enter the US market with confidence.
Get a free compliance assessment from our specialists — no obligation.
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