We combine years of operational experience with the latest in AI technologies to deliver a seamless and advanced, client experience. Our culture fosters collaboration, creativity, and the sharing of knowledge with the broader community in the common pursuit of improving drug and patient safety.
All in one solution for collection and management of pharmacovigilance regulatory intelligence
Our unique digital solutions address the critical business gaps in current PV systems:
Long history working exclusively with the Argus safety database including implementation, validation, and support for both small and large biopharma clients.
Local and regional regulatory authorities are constantly updating safety information which requires reference safety data and labeling to be updated. This is time-consuming for a QPPV. iVigee has created a monitoring solution that performs these tasks.
Knowledge management system offering a current view of PV requirements for 90+ countries. All kept up-to-date by a network of local experts, our team of PV professionals, and the community of iViReg users.
Pharmacovigilance (PV) ensures the safety of medicines by monitoring and assessing adverse drug reactions (ADRs) as well as other safety measures throughout the product lifecycle. This includes activities during clinical trials, marketing authorization, and post-authorization phases, covering risk management, periodic safety updates, signal detection, and regulatory compliance. Regulatory intelligence in PV helps organizations stay compliant with evolving requirements, enabling them to understand and implement national and global safety regulations effectively.
Pharmacovigilance spans the entire lifecycle of a medicinal product, beginning with clinical trials, continuing through marketing authorization, and extending into post-authorization monitoring. Each stage involves safety data collection, risk assessment, and regulatory compliance to protect patient health.
PV regulatory intelligence ensures organizations involved in medicinal product development and safety remain informed about local ADR reporting requirements, including what must be reported, timelines, submission formats, and language specifications. This knowledge is essential for maintaining compliance with national and regional regulations.
Whatever your pharmacovigilance requirements, our world-leading technology platforms and globally experienced operational teams can provide the solution.
