Operations & Technology

Operational and technological aspects of IMP management consulting we cover:
  • IMP Project Management
    • Introduction of efficient methodologies and taking over project management activities to free up your resources, specifically of outsourced projects
    • Take over of the entire IMP supply chain for individual studies or entire projects
  • Auditing of contract manufacturers
  • Inspections: preparation and MOCK Inspections
  • Documentation
    • Establishment of SOPs, RFPs, User Requirement Specifications for IVRS/IWRS and MES, and Product Specification Files
    • Review of batch documentation
  • Conduction of User Acceptance Tests for IVRS/IWRS and MES
  • Technological Aspects, e.g.:
    • Randomisation & Labelling / Barcode controlled Labelling Systems
    • Inventory Management & Distribution
    • MES and IVRS/IWRS in IMP management
    • Automation in IMP packaging
    • Value opportunity assessments (equipment, software, facilities, sites)
    • Technology Transfers

Project References