CordenPharma’s clinical trial units operate in close collaboration with formulation development and commercial manufacturing to take advantage of the full range of capacities, resources and complete big pharma infrastructure offered by all of CordenPharma’s global facilities. They are comprised of:
  • Analytical development department
  • Purchasing department
  • QP services  
  • Storage, distribution & logistic services

Clinical Trial Services Include:

  • Clinical Manufacturing
    • Non-sterile liquids and suspension
  • Comparators
    • Comparator procurement
  • Label Printing and Labeling
    • Label layout and approval
    • 100% inspection of all clinical labels (four-eyes principle)
    • Documented 100% reconciliation
    • Generation of randomisation lists
    • Code-breaking envelopes
    • Multi-lingual booklet labels and wrap around labels
  • Packaging / Pre-production Service
    • Interpretation of study protocols and conversion into optimised packaging design 
  • Secondary Packaging
    • Syringes, vials and ampoules, visit boxes, patient kits, centre boxes, shipment boxes, graphic packaging design
  • Analytical/ QA-Service
    • In-house lab
    • Analytical method development, method transfer and method validation
    • Stability tests according to ICH
    • Release testing
    • Issuance of CoA
    • QP release
  • Storage
    • Dedicated shipping warehouse area
    • Commercial warehouse
    • Cold Storage Room @ 2-8°C
    • Cold Storage Room and Freezer Storage @ -20°C
  • Distribution
    • Worldwide distribution
    • IVRS / IWRS
    • Shipment tracking with modern communication systems
    • Cold chain distribution management, including refrigerated and frozen shipment
    • Data logger system
    • Return drug reconciliation and management
    • Certified destruction

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