Acting as European Marketing Authorization Holder for a US Headquartered Biopharmaceutical Company, and Continual Pharmacovigilance System Maintenance
A biopharmaceutical company that focuses on immune-stimulatory and immune-derived therapies to combat infectious diseases asked SFL to file a Marketing Authorization Application on their behalf in the EU, to act as Marketing Authorization Holder and manage the European Pharmacovigilance (PV) system.
SFL successfully filed for and obtained a Central Marketing Authorization. In addition, SFL provides EU QPPV/Deputy services ensuring EU QPPV oversight of the entire PV system as well as Local Qualified Persons for Pharmacovigilance (LQPPVs) in the EU and the UK. The SFL PV team works in close collaboration with the company`s global PV Service Provider and managed to set up and maintain a compliant PV system described in the EU and UK PSMF.