At a Glance FDA's new rule requires contact info for adverse-event reporting on primary and secondary packaging. The software provides a URL or QR code for packaging, tracks events, and formats them for FDA reporting. The developer, Registrar Corp., says it is developing versions for other industries.   Registrar Corp. has launched adverse event management (AEM) software in response to FDA’s Modernization of Cosmetics Regulation Act (MoCRA). The new regulation stipulates that contact information for reporting adverse events must be displayed on both p...

By Cassandra Stern As cosmetics and personal care product manufacturers and suppliers turn to digital solutions for MoCRA compliance, Registrar Corp's recently released Cosmetic Adverse Event Management (AEM) software has emerged as an additional solution for navigating ongoing regulatory changes....

US compliance specialist Registrar Corp has launched Adverse Event Management (AEM) Software, said to be a first-of-its-kind software package that enables cosmetics companies to comply with the Food and Drug Administration's (FDA)’s Modernization of Cosmetics Regulation Act (MoCRA). The AEM platform securely intakes sensitive 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. MoCRA regulations will not only impact compliance and regulator...