SafetyCall International, LLC
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Bloomington, MN 55431
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FDA Adverse Event Reporting Services: A Step-by-Step Process Guide
April 16, 2026  | FDA Adverse Event Reporting Services: A Step-by-Step Process Guide When a reportable adverse event reaches your organization, the first question is: how much time do you…
man inspecting assembly line of cosmetics
Adverse Event Management Services: Comprehensive FDA Solutions for Regulatory Compliance
April 16, 2026  | Adverse Event Management Services: Comprehensive FDA Solutions for Regulatory Compliance TL;DR, Key Takeaways Adverse event (AE) management is a regulatory requirement... Reporting timelines vary by product…
FDA Launches AEMS: What the New Adverse Event Monitoring System Means for Your Industry
March 11, 2026  |  FDA Announcements, Adverse Event Reporting On March 11, 2026, the FDA officially launched the Adverse Event Monitoring System (AEMS), a unified platform designed to consolidate the…
FDA Publishes Draft Guidance on MoCRA Cosmetics Records Access Authority
FDA Publishes Draft Guidance on MoCRA Cosmetics Records Access Authority
The U.S. Food and Drug Administration (FDA) today published draft guidance clarifying its authority to access and copy cosmetic company records under the Modernization of Cosmetics Regulation Act of 2022…
Health Hazard Evaluations: A Critical Component of Manufacturing Quality and Product Safety Management
In the complex landscape of product manufacturing and regulatory compliance, quality deviations represent significant business and, in some cases, public health challenges. When manufacturing or other product related safety anomalies…
SafetyCall: Your Trusted Partner in Adverse Event Management and Regulatory Compliance 
SafetyCall International, the world's largest provider of adverse event management services for humans and animals, has been helping manufacturers navigate complex regulatory landscapes for over 20 years. As the only…
SafetyCall International Named a Minnesota Star Tribune Top Workplace for the 15th Year 
We are thrilled to announce that SafetyCall International has been recognized as a Minnesota Star Tribune Top Workplace for the 15th year! This recognition comes directly from our employees' feedback…
Adverse Event Reporting Now Required for Cosmetic Products
It is a little-known business story that sounds too good to be true. A small start-up company from Minneapolis transforms consumer product safety across an entire industry – and then…
FDA updates 3500A instructions to provide direction for mandatory cosmetics reporting
FDA released an updated guidance for industry to include instructions on mandatory adverse event reporting for cosmetics. Mandatory reporting was included in the sweeping legislative update for cosmetics last year,…
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