A global pharma company needed pharmacovigilance expertise following a European Medicines Agency inspection which resulted in several critical findings. They required a robust pharmacovigilance system that is compliant with the requirements of the FDA, EMA, and other national health authorities.
Qinecsa implemented a fully compliant pharmacovigilance framework in line with US, Canadian, and European regulatory requirements.
Join Qinecsa at 32nd Pharmacovigilance 2023 to discuss the latest developments in pharmacovigilance, drug safety & risk management.Our President, Humaira Qureshi, will present ‘Fit for future sourcing for pharmacovigilance’ where she will discuss the drivers for...
Qinecsa provides tailored signal detection and risk management services for clinical and commercial products, including associated benefit-risk management activities. With diverse therapeutic expertise and industry-leading technology, our team support the breadth and...
The Commonwealth Vigilance Workbench (CVW) signal detection platform spans the full spectrum of the signal management process to ensure all potential signals are tracked with clear prioritization. Robust data integration and functionality enables analysis of aggregate...