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Registrar Unveils Software To Assist MoCRA Stakeholders In Filing Adverse Event Reports

 
• By Eileen Francis

Registrar Corp. introduces Adverse Event Management Software that ‘securely’ intakes sensitive consumer medical data, tracks adverse events for all products globally, transmits information to internal stakeholders and formats serious events to the FDA Medwatch format for submission.

Adverse Event

Regulatory consultancy firm Registrar Corp. has launched Adverse Event Management (AEM) Software to assist cosmetic companies as they seek to comply with serious adverse event reporting requirements under the Modernization of Cosmetics Regulation Act.

Noting in a 23 July release that many cosmetic companies are ill-prepared for FDA’s new adverse event requirements, the Hampton,...

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More from Policy & Regulation

EU’s Small, Medium Beauty Industry Pushing For Clarity In Revised CPR

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