toclinco offers state of the art pharmacovigilance services for medicinal products in accordance with national and international regulations (refer e.g. to EudraVigilance or U.S. FDA Drug Safety Reporting or good pharmacovigilance practices (GVP)).

Our services can include:

  • Set-up, maintenance and remedation of global pharmacoviglance quality management systems (e.g. GVP SOPs)
  • Preparation of audits and inspections
  • Training of company personnel
  • Preparation and provision of GVP training material - PV training
  • Benefit-risk analysis of medicinal products
  • Set-up, maintenance and implemetation of safety data exchange agreements (SDEAs) with different stakeholders (e.g. distributors, business partners)
  • Function as Stufenplanbeauftragter and Informationsbeauftrager according to AMG