WHAT WE ARE DOING

Transport Validation
- Risk Management
- Validation Master Plan
- Validate Ocean Shipping
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Outsourced
- Conduct Triage
- Prevent Glass Breakage
- Support Clinical Trial
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Clinical Trial Operations
- SOPs and risk mitigation
- Freezer qualification
- Zone 4 clinical trials
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Staff Augmentation
- Assess current program
- Implement new approach
- Support on-going filings
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Staff Augmentation
- Qualification support for pipeline
- Improve packaging
- Improved testing methods
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Cold Chain Logistics
- Enhance regulatory compliance
- Qualification process redesign
- Monitoring and controls
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Thermal Packaging Engineering
- Design deep frozen shipper
- Characterize sublimation rates
- Qualify cryogenic shipper
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Transport Simulation
- Product formulation testing
- Shipping qualification
- Prepare FDA meeting
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Cold Chain Logistics
- Reduce total delivered cost
- Assess risk and mitigate
- Implement new technology
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Clinical Trial Operations
- Transition operations
- Address operational needs
- Day-to-day technical support
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Staff Augmentation
- Qualification support for pipeline
- Improve packaging
- Improved testing methods
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Transport Simulation
- Trailer Qualification
- Drug Product Testing
- BLA Review
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Integrated Expertise
- Assess Gaps
- Triage Operations
- Qualify Packaging
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Technology
- Competitive analysis
- Environmental sustainability
- Evaluate impact
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Technology
- Total delivered cost
- Active vs. passive refrigeration
- Operational impact
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These Case Studies Below Are Available Upon Request

Case Studies