As the global leader of temperature-controlled logistics solutions to the life sciences industry, we have the long-standing experience and expertise to deliver critical information to support your strategic business decisions for research, clinical and commercial programs.
Through Cryoport’s consulting services, you have access to the industry’s best technical resources in engineering, design and logistics. Delivering key business differentiators and risk mitigation processes, our experts support your distribution needs for critical materials, including research, clinical and commercial drug product materials.
Shipping Risk Assessment
Shipping Lane Validation
Global Regulatory and Trade Services
Training/Onboarding ServicesOur team takes an unbiased approach to analyze historical Cryoportal data relative to your specific lanes and selected carriers. The result is a Shipping Risk Assessment Report that includes a set of metrics, KPIs and supplemental information to guide your shipping plans.
Cryoport’s shipping lane validation proactively determines and addresses threats that could negatively impact biological products or sample integrity during transportation in a quality technical report. Our Quality team will work with you to develop and execute a Validation Protocol on your critical shipping lanes with real test shipments.
Cryoport provides a wide range of offerings within our Global Regulatory and Trade Services. Prior to shipping, our team can advise on lane import and export regulations, guidance on possible permits or certificates needed, and review your supporting shipment documentation. We can help navigate through the complexities of clearance. Our team of consulting experts are dedicated to enhancing your trade compliance to mitigate potential delays impacting your valuable, life-saving shipments. Download our brochure for more information: Global Regulatory and Trade Services Brochure
Our team provides comprehensive training covering Cryoport products, services and technology. The training and onboarding is led by Cryoport Subject Matter Experts and can be done remotely or on site.
SOPs and Documentation
Packaging Validation
Packaging and Accessory Design
Program ManagementStandardized and clear-cut SOPs are essential to establish and sustain a robust Quality System. Cryoport provides the documentation you need to understand and utilize our Cryoportal®, Cryoport Express® Shippers and SmartPak II™ Condition Monitoring System.
Cryoport provides Packaging Validation against IATA and ISTA standards. We cover all packaging — including primary, secondary, etc. up to shipper level.
The design of custom packaging and accessories are collaborative projects with support from Cryoport Engineering, Supply Chain, Operations, Quality and Customer Support teams. We encompass all phases of package and accessory design from concept development, product design, product development to product implementation.
All Consulting projects are managed by our Program Management team to oversee all project activities through completion. A Program Manager is assigned to individual or bundled projects to ensure the successful implementation and execution of clinical trial preparations, commercial readiness and ongoing program support.
A Leap Forward in Standardizing the Regenerative Medicine Supply Chain – What the New ISO 21973 Guidance Means for Cell and Gene Therapy Developers
Cryoport® is a trademark of Cryoport, Inc. and used with permission by Cryoport Systems, LLC
