What it is
MoCRA requires a US contact for adverse events and submission of serious adverse event reports to FDA within 15 business days. We provide the intake channel, record-keeping, triage, and on-time reporting.
Who needs it
Responsible persons for cosmetic products marketed in the US.
What's included
- US contact channel for consumer adverse events
- Structured intake and record-keeping
- Triage of serious events by specialists
- On-time serious-report submission to FDA
How it works
- 1
We set up your US adverse-event contact channel.
- 2
Reports are recorded and triaged as they arrive.
- 3
Serious events are reported to FDA within the required 15 business days.
Frequently asked questions
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