Auditing Experience

  • Investigational sites
  • Contract Research Organizations (CROs)
  • Sponsors (self- and mock-inspections)
  • Trial Master Files (TMFs)
  • Clinical study reports
  • Analytical laboratories
  • Data management / biostatistics
  • Investigational medicinal products distributors


Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Russia, Slovak Republic, Spain, Sweden, Switzerland, Ukraine, United Kingdom, USA (> 120 audits)

QA Experience

  • GCP-compliant quality system
  • Corrective and preventive actions (CAPAs)
  • Standard Operating Procedures (SOPs)
  • Inspections by European competent authorities
  • Quality assurance documentation
  • Consultancy in GCP, regulatory requirements
    and study conduct

Clinical Trial Experience

  • Clinical trials: phase I-IIIb, first-in-man
  • Investigator initiated trials (IIT)
  • Non-interventional studies (NIS)
  • Pharmacokinetic studies
  • Planning and conduct of clinical trials
  • Innovative investigational medicinal products
  • Key therapeutic areas
  • Rare diseases