• QM-systems according to ISO 9001
  • QM in pharmacovigilance according to the European “Guideline on Monitoring of Compliance with Pharmacovigilance Regulatory Obligations and Pharmacovigilance Inspections“
  • QM in pharmaceutical distribution according to „Good Distribution Practice“
  • SOP preparation and revision
  • Internal audits
  • Training and moderation
  • Vendor-/ Partner Audits
  • Pharmacovigilance Audits
  • Preparation and Follow-up of Pharmacovigilance Inspections


  • Qualified Person for Pharmacovigilance in the EU
  • Commissioner for the Graduated Plan according to German Drug Act
  • 24 hours preparedness for SAE reporting in clinical trials
  • Complete case processing, including MedDRA-coding, narrative-preparation and authority submission (paper and electronically)
  • Pharmacovigilance database
  • Pharmacovigilance studies and registries
  • Literature research
  • Preparation of pharmacovigilance and risk management plans
  • Implementation of pharmacovigilance systems
  • Training


  • Literature research and analysis
  • Scientific assessment reports
  • Processing of scientific publications for marketing and sales purposes
  • Medical translations
  • Preparation of “Summary of Product Characteristics” and “Instructions for Use”
  • Information responsible according to German Drug Act
  • Clinical evaluation reports for medicinal products according to MEDDEV 2.7.1