Operations & Technology Projects
  • Several US and Germany headquartered, major multinational pharmaceutical and small biotech companies (based on current regulatory GxP requirements)
    • Project Management of Ph I-IV trials (small Ph I to big international Ph III), incl. IMP vendor selection and outsourcing management
    • Several GxP compliance audits at vendors
    • Development of IT supported barcode-controlled labelling system
    • Selection of IVR / IWR systems for international trials, compilation of User Requirement Specifications and conduction of User Acceptance Tests
    • Development and establishment of GMP SOPs for IMP process
    • Development of a Pharmaceutical Development Handbook