Efficient End to End Pharmacovigilance services according to GVP

  • The marketing authorisation holder in the EU should continuously monitor the safety of their medicinal products and inform the authorities of any new information that might have an impact on the marketing authorisation [DIR Art 23(2), REG Art 16(2)](GVP Module IX)
  • Client was rapidly increasing portfolio with M&A with over 1500 marketing authorizations with complex partner network systems
  • Implement a process for integrating the activities performed by PharmaLex into the client’s system