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...

24 Jul 2024 --- US-based Registrar Corp introduces a “first-of-its-kind” Adverse Event Management (AEM) software to help cosmetics companies comply with the FDA Modernization of Cosmetics Regulation Act (MoCRA). The company says it is the world’s largest FDA compliance company, with 32,000 clients in 190 countries, and claims industry players are not prepared for the FDA’s new adverse events requirements, which were previously voluntary. An adverse event is “any health-related event associated with the use of a cosmetic product that is adverse,” according to the Feder...

Corp. has announced the launch of Adverse Event Management (AEM) software to enable cosmetics companies to comply with the U.S. Food and Drug Administration’s (FDA's) stringent mandates for adverse event reporting under the new Modernization of Cosmetics Regulation Act (MoCRA). 5 MoCRA Mandates for Adverse Event Reporting Per Registrar Corp., MoCRA mandates reporting based on the FDA’s medical device and drugs reporting process, including: Display contact information on both the primary and secondary packaging; Collect detailed personal and medical inform...

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 •...