Specialized Aggregate Reporting Services with a Focus on Patient Safety & Product Quality

Pharmaceutical sponors, medical device manufacturers and Market Authorization Holders (MAHs) have the mandatory legal obligation to prepare and submit Aggregate Safety Reports to regulatory bodies as per the requirements described in the ICH Guidelines.

Aggregate Reporting is as an assurance that companies are continously monitoring patient safety and communicating risks to healthcare providers and patients from time to time. These safety reports are typically submitted to regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and are used to inform safety-related decisions, including product labeling, risk management plans, and regulatory action. 

We deliver Aggregate Report Services leveraging our TOTALVigilance framework that is a cost-effective, flexible, and scalable solution designed to reduce manual effort through digitalization, automation, and real-time oversight. It combines expert knowledge, lean processes, and modern technology to deliver high-quality, compliant services. With adaptable service models and seamless integration into your existing systems and workflows, TOTALVigilance enhances operational efficiency, enables proactive oversight, and maximizes return on investment.