+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz


Quality Management System according to the GVP and audits

Good pharmacovigilance practices (GVP) are measures introduced for the aim of facilitating the performance of pharmacovigilance activities in the European Union (EU).  GVP applies to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States and cover medicines authorised centrally via the Agency as well as medicines authorised at national level.

Di Renzo Regulatory Affairs has a special unit dedicated to pharmacovigilance, offering a series of services for GVP compliance. The main services offered in this sphere are:

  • Drafting and review of standard operative procedures (SOPs) and Pharmacovigilance Operative Instructions
  • Preliminary and supporting consultancy activities following inspection notice or audits by business partners
  • Consultancy activities in the management and planning of Corrective and Preventive Actions following inspection findings
  • Performance of pharmacovigilance audits according to the GPV