Good Pharmacovigilance Practice (GVP) is a quality system for locating, reporting, understanding, preventing and managing adverse events (adverse reactions) and quality issues that are connected with pharmaceuticals. Likewise BioPlan provides support for medical devices and diagnostics vigilance systems.
The pharmaceutical and device license owner in Israel has a legal obligation to report all adverse events and quality issues and be aware of all issues concerning his licensed medication/product.
BioPlan’s experienced PV team provides a complete and efficient working Pharmacovigilance controlled quality system including ongoing management of this system, training your staff and customers.
BioPlan offers a QPPV service required by local Israeli regulations. We also provide the legally required reporting to the Israeli MoH and will make sure you are in compliance with the manufacturer’s demands and international reporting requirements. BioPlan’s team are expert in providing this kind of support and management including support and presence before and during all kinds of audits that you are required to undergo.
BioPlan provides PSUR writing services. Our PV team provides versatile training and auditing services, including medical device and other health industries.