What We Are Doing

Shipping Validation Master Plan

• Qualify Thermal Packaging
• Create Validation Master Plan
• Execute Transport Simulation

Transport Simulation

• Risk assessment
• Qualify thermal shipping systems
• Execute transport simulation

Outsourced

• Conduct Triage
• Prevent Glass Breakage
• Support Clinical Trial

Clinical Trial Operations

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

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

Technology

• Competitive analysis
• Environmental sustainability
• Evaluate impact

Technology

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