Registrar Corp Launches Adverse Events
Management Software for FDA MoCRA Compliance
HAMPTON,
Va., July 23, 2024 /PRNewswire/
-- Registrar Corp, the world's largest FDA compliance
company with 32,000 clients in 190 countries, announced today the
launch of Adverse Event Management (AEM) Software. The
first-of-its-kind software enables cosmetics companies to comply
with the U.S. Food and Drug Administration's (FDA) Modernization of
Cosmetics Regulation Act (MoCRA).
Cosmetics Companies Are Not Prepared for FDA's New Adverse
Events Requirements
MoCRA has new, stringent requirements for Adverse Events
reporting based on the FDA's medical device and drug adverse events
reporting process including:
- Display contact information on both the primary and secondary
packaging
- Collect detailed personal and medical information from the
consumer
- Investigate to determine if the adverse event is a "serious"
event
- Report "serious" adverse event to the FDA within 15 business
days
- Record all health-related adverse events and maintain for up to
6 years
The new regulations will not only impact compliance and
regulatory departments but require tight coordination with
marketing (product labeling), quality and manufacturing
(investigation), legal (consumer liability), and R&D
(formulation safety).
"MoCRA's Adverse Reporting requirements are incredibly complex
and the existing consumer complaints process simply will not work,"
said Jaclyn Bellomo, Registrar's
Senior Director of Cosmetic Science and Regulatory Affairs. "The
consumer's medical data needs to be securely collected, processed
in real-time, and investigated quickly to meet the 15-day serious
adverse reporting requirement."
Registrar's Adverse Event Management (AEM) software has been
purpose-built for cosmetics companies. The AEM platform securely
intakes sensitive consumer medical data, tracks all adverse events
for all products globally, transmits information to internal
stakeholders, and formats serious adverse events to the FDA
MedWatch format for submission to the FDA.
Key Benefits of Registrar's Adverse Event Management
Software:
- Consumer-friendly intake: Consumers can quickly
scan a QR code on the label and enter the required data, photos,
and documents needed to quickly investigate
- Real-Time Tracking & Monitoring: Monitor
adverse events globally for every SKU in real time and get the
earliest indicator of potential safety or quality issues
- Protect Medical/Personal Data: ISO27001-certified
security for storage and transmission of medical and personal
identifiable information (PII)
- FDA MedWatch-ready: Serious adverse event reports
pre-formatted to the FDA requirements for quick upload and
submission
"In the past six months, we have helped over a thousand
cosmetics companies get MoCRA ready with product listings,
registrations and label reviews," said Raj Shah, CEO of Registrar
Corp. "As FDA enforcement now ramps up and retailers press on
brands to get fully MoCRA compliant, we recognized the urgent need
to solve their Adverse Events need with our AEM software."
To learn more about Registrar Corp's Adverse Event Management
Software, visit our website.
About Registrar Corp
Registrar Corp is the world's largest FDA compliance
company with over 32,000 clients in 190 countries. Our
software, services, and training help cosmetics, food, drug and
medical device clients comply with complex FDA regulations and keep
people healthy and safe.
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SOURCE Registrar Corp