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.

Who submits reports to FAERS under MoCRA?

Anyone (Healthcare professionals, consumers, and drug manufacturers) can submit the report to FEARS. They can report side effects they experience from a medication, medication errors you make, or problems they have with the quality of a drug or biologic product.

Drug manufacturers can analyze the data to identify potential safety issues with their products, leading to improvements.

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

What are the best practices for Adverse Event Reporting?

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.

How does QSS help in adverse event reaction reporting?

We assist by ensuring you follow the right protocols and have efficient systems in place for managing the reports themselves.
We offer expert solutions to prepare FDA adverse reaction reports. Former FDA officials can guide you through the process.
We ensure complete and accurate reporting. Whether it’s Grade 4 adverse drug reactions or other incidents, we provide assistance1.
We can serve as a US Agent and support global customers in multiple languages.

Need assistance for Adverse Event Reaction Reporting?

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

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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

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