Growing complexities in foreign risk compliance
Global Regulatory Landscape
Section C.01.050 of the Food and Drug Regulations requires pharmaceutical companies to notify Health Canada of foreign risk communications, recalls, and safety-related actions for drugs marketed in Canada. This ensures timely regulatory oversight and safeguards public health.
Also, the Procedure 6, titled "Reporting of Side Effects and New Safety Information," is a directive issued by the Israeli Ministry of Health (MoH) that outlines the requirements for reporting (ADRs) and new safety information related to medicinal products.
Therapeutic Goods Administration (TGA) in Australia has specific requirements for reporting foreign regulatory actions related to medical devices.
An increasing number of regulatory bodies (FDA, EMA, PMDA, HSA and ANVISA) are implementing strict timelines for reporting foreign regulatory actions that affect drug substances and drug products.
Our Approach
To address these evolving regulatory demands, we have developed a technology-driven pharmacovigilance solution that automates compliance workflows and simplifies global reporting obligations.
The RegAlert™ Dashboard is an AI-powered intelligence platform designed to enhance Pharmacovigilance Risk Reporting. By leveraging Automated Intelligence and Natural Language Processing (NLP), it streamlines risk monitoring, accelerates decision-making, and improves regulatory alignment—empowering pharmaceutical companies to stay ahead in compliance.
- Automated Risk Intelligence – RegAlert™ Dashboard monitors risk communications, recalls, and safety actions from 30+ health authorities, streamlining compliance and eliminating manual tracking.
- Centralized Compliance Hub – A single, secure repository for risk communications, improving accessibility and collaboration.
- Custom Reports & Notifications – Access and download reports in multiple formats for timely impact assessment.
- Fully Customizable – Tailored to meet unique customer needs with flexible features and workflows.
- Simple and Efficient – A user-friendly interface delivering AI-driven insights for risk classification.
Conclusion
In an era of increasing regulatory complexity, RegAlert™ Dashboard offers a scalable and intelligent solution to help life sciences companies stay compliant, proactive, and globally connected.