The growing importance of pharmacovigilance (PV) can sometimes be perceived as a burden to pharmaceutical companies, who are ultimately responsible for drug safety and ensuring compliance with constantly evolving international regulations.
Meeting the challenges of monitoring medical drug effects in-house can put pressure on time and resources. The slightest error in the pharmacovigilance reporting procedures can have costly and risky consequences, not to mention their effect on patient health. Outsourcing these activities to a specialised and compliant pharmacovigilance consultancy firm is a flexible solution to the constant demands of maintaining an in-house operation.
At BlueReg, our dynamic and adaptable team will help you make pharmacovigilance a more streamlined process, ongoing support and constant feedback. We offer expert advice and tailored consultancy to assist you with a complete range of pharmacovigilance services.
Risk management & PV case processing
We support safety data collection and reporting of individual case safety report (ICSRs) in accordance with GVP on a broad portfolio of products, reference and generic medicines in all therapeutic areas. Our pharmacovigilance team provides comprehensive global safety and medical services, including safety case management, medical safety and writing (DSUR/PSUR-PBRER), signal detection and surveillance. We assist pharmaceutical and biotech companies to maximize product performance by managing risk before, during, and after marketing authorisation.
Pharmacovigilance organisation and system
We provide advice on the organisation of your in-house pharmacovigilance department and on setting up PV system. We can help with the preparation of the Pharmacovigilance System Master File (PSMF) and associated documentation (SOPs, SDEA…).
Moreover, BlueReg conduct PV audits according to your needs and GVP to identify potential issue or gap at different stages of your safety processes. Our experts propose solutions or advice to resolve compliance issues in a cost-effective and planned manner before PV inspections by regulatory authorities so that you can experience them with confidence.
Qualified Person for Pharmacovigilance QPPV
Whether you decide to outsource all or part your PV activities or keep them in-house, BlueReg offers (at your disposal) EU Qualified Person for Pharmacovigilance (QPPV), local QPPV (France) and Deputy with extensive knowledge and experience of the pharmaceutical industry.