What it is
Everything MoCRA requires, managed as one annual program: facility registration, product listing, US Agent representation, label compliance, adverse-event readiness, and safety substantiation guidance — with a named specialist who knows your business.
Who needs it
Brands that want complete MoCRA compliance handled by one team — especially foreign brands entering the US market.
What's included
- FDA facility registration and renewals
- Product listing for your full catalog
- US Agent representation
- Label compliance, adverse-event readiness, and safety substantiation guidance
How it works
- 1
We assess your products and facilities in a free consultation.
- 2
An AI-powered gap analysis shows exactly what MoCRA requires for you; your specialist confirms the plan.
- 3
We execute the full program and keep you compliant year after year.
Frequently asked questions
Ready to start?
Get a free compliance assessment for your products.