SafetyCall International, LLC
3600 American Boulevard W, Suite 725
Bloomington, MN 55431
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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…
Adverse Event Management
Regulatory Compliance
Services
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…
Award
Top Workplace
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,…
What We Know About MoCRA
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the first major change to FDA’s cosmetics authorities since the passage of the Food, Drug, and Cosmetic Act in 1938.…
FDA Food Safety Compliance Initiatives
Presently, although there is no requirement for submitting individual adverse event human case reports involving food products to the FDA the Agency does have the expectation that manufacturers have a…
EPA and FDA CVM Hold Joint Public Meeting to Hear Comments on Modernization Plan
Last Wednesday, March 22nd, several members of SafetyCall’s regulatory team sat in on EPA and FDA’s Center for Veterinary Medicine (CVM) first joint public meeting in which they presented a…
Proposed Change of Agency for Oversight of Animal Health Products
This past Wednesday, March 1st, EPA and FDA’s Center for Veterinary Medicine hosted a joint information session for industry stakeholders regarding a proposed change of agency for oversight of animal…
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