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 FDA adverse event reaction reporting?

FDA Adverse Event Reaction Reporting (FAERS) is a database for the FDA, which tracks safety concerns after drugs and biological products hit the market. It collects reports of side effects, medication errors, and product quality issues. Under the MoCRA (Medical Device and Cosmetic Act), cosmetic manufacturers have a crucial obligation to report serious adverse events associated with the use of cosmetic products within the United States. Learn about New Tools for MoCRA Compliance. 

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

How does QSS help in adverse event reaction reporting?

Need assistance for Adverse Event Reaction Reporting?

Fill the form below and connect with Former FDA MoCRA experts.

0/5 (0 Reviews)

Don't miss updates from Health Canada and FDA.

If you are looking for the latest regulatory updates or want the newest regulatory requirements guides, please leave your email and we'll keep you posted.

We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. Privacy Policy.