Case Studies

  • Transport Validation

    • Risk Management
    • Validation Master Plan
    • Validate Ocean Shipping
  • Staff Augmentation

    • Assess current program
    • Implement new approach
    • Support on-going filings
  • Staff Augmentation

    • Qualification support for pipeline
    • Improve packaging
    • Improved testing methods
  • Cold Chain Logistics

    • Enhance regulatory compliance
    • Qualification process redesign
    • Monitoring and controls
  • Thermal Packaging Engineering

    • Design deep frozen shipper
    • Characterize sublimation rates
    • Qualify cryogenic shipper
  • Transport Simulation

    • Product formulation testing
    • Shipping qualification
    • Prepare FDA meeting
  • Cold Chain Logistics

    • Reduce total delivered cost
    • Assess risk and mitigate
    • Implement new technology
  • Clinical Trial Operations

    • Transition operations
    • Address operational needs
    • Day-to-day technical support
  • Staff Augmentation

    • Qualification support for pipeline
    • Improve packaging
    • Improved testing methods
  • Transport Simulation

    • Trailer Qualification
    • Drug Product Testing
    • BLA Review
  • Integrated Expertise

    • ¬†Assess Gaps
    • Triage Operations
    • Qualify Packaging
  • Outsourced

    • Conduct Triage
    • Prevent Glass Breakage
    • Support Clinical Trial
  • Clinical Trial Operations

    • SOPs and risk mitigation
    • Freezer qualification
    • Zone 4 clinical trials
  • Technology

    • Competitive analysis
    • Environmental sustainability
    • Evaluate impact
  • Technology

    • Total delivered cost
    • Active vs. passive refrigeration
    • Operational impact

These Case Studies Below Are Available Upon Request

X




We will never share your info with a 3rd party.