Efficient & Reliable FDA Adverse Event Reaction Reporting Solutions

Gain compliance with FDA Adverse Event Reaction Reporting (FAERS) and stay on top of MoCRA’s mandates. Ensure potential safety issues with your products once they’re out in the market to avoid penalties and maintain market access.

QSS assists you with a personalized approach, advanced technology, ensuring you receive accurate, timely, and hassle-free reporting, so you can focus on what matters most—your business.

Connect with Former FDA MoCRA experts by filling out the form below.

What is the deadline for sending the report?

FDA requires all cosmetic adverse event reporting within 15 business days from the moment the company becomes aware of the event. Any suspected adverse events or any adverse events that are considered serious and unexpected must be reported to the US FDA. Click here to see our pricing

Companies within the cosmetic industry should adopt the following recommended practices:

Implement a comprehensive system to identify and investigate adverse events, ensuring compliance with MoCRA reporting requirements.
Provide thorough training on recognizing, reporting, and recording adverse events according to established protocols.
Maintain detailed records of adverse events associated with cosmetic product use for at least six years.
Submit adverse event reports to the US FDA within 15 business days, including a copy of the product label.
Monitor reports for emerging trends and take corrective action promptly to address safety concerns.

Need assistance for Adverse Event Reaction Reporting?

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