Human medicinal products

The development of the new pharmacovigilance legislation, which was the biggest change to the regulation of human medicines in the European Union (EU) since 1995, was based on the observation that adverse drug reactions (ADRs), ‘noxious and unintended’ responses to a medicine, caused around 197,000 deaths per year in the EU.

We offer you

  • Compliance with guidelines on Good Pharmacovigilance Practice
  • Services of a Qualified Person for Pharmacovigilance (QPPV), 24/7 availability
  • Establishment and maintenance of the Pharmacovigilance System Master File (PSMF) and Quality System
  • Establishment and maintenance of the Pharmacovigilance and Quality System for wholesalers, parallel importers/distributers, etc.
  • Client-tailored SOPs, working practices, trainings of personnel
  • Setting up appropriate Contractual arrangements and supervision
  • Management and reporting of adverse reactions to medicinal products
  • Weekly Literature Searches
  • Ongoing benefit-risk evaluation
  • Preparation of Risk Management Systems and Risk minimisation measures
  • Medical writing (PSUR, RMP, protocols, etc.)
  • Additional Monitoring
  • Signal management
  • Regulatory action
  • Management of Patient Support Programs
  • Electronic transmission of the pharmacovigilance data (Article 57), selection of appropriate tool and implementation of quality system
  • Audit of internal departments, affiliates or external partners
  • Pre-inspection consultations