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HAMPTON, Va. — Registrar Corp, the world’s largest FDA compliance company with 32,000 clients in 190 countries, announced the roll out 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).
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.”
