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 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 Corp'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 Corp's AEM software has been purpose-built for cosmetics companies.
“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.”
