Consulting Services

Identify, quantify, and mitigate risks before they impact product integrity

Shipping Risk Assessments provide a structured approach to identify and prioritize thermal, handling, timing, and compliance risks across your end-to-end transit journey. We analyze product sensitivity, packaging performance, process steps, and lane variables to build a realistic risk profile tied to consequence and likelihood. Our team models environmental exposure and operational handoffs, including airport/cargo dwell time, customs clearance delays, and last-mile deliveries. We define continuous monitoring and data handling that regulators expect and operations can act on. Findings translate into specific controls like pack-out evaluation, handling recommendations, contingency triggers, and communication matrices. The outcome is a defensible risk register and mitigation plan that reduces variability and supports both quality and regulatory narratives. You get clarity on where to invest qualification effort next and how to measure success.

By converting abstract concerns into quantifiable risks, you can prioritize the controls that deliver the highest reduction in variability. The assessment ensures your teams focus resources where they matter most while avoiding over-engineering of lower-impact items. It gives quality and regulatory stakeholders the documentation they need to make confident decisions and defend them. As your program scales, we revisit assumptions and update the risk assessment to reflect new lanes, volumes, and care sites/partners. The risk framework becomes a strategic framework for your qualification strategy and supports repeatable decisions across sites and geographies at scale. It also accelerates audit and inspection readiness by connecting risks to documented controls and evidence. Most importantly, it equips your teams to keep therapies safe while timelines move faster.

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Design and qualify the domestic and international routes your program needs

Shipping Lane Qualifications translate your risk controls into verified performance on the actual routes you’ll use. We identify and select lanes based on a wide range of criteria, including operational feasibility, seasonality, regulatory considerations, and historical lane performance based on our track record of shipment success that spans decades and accounts for more than a million successful shipments. Our approach blends simulation with live pilots to validate transit duration, environmental exposure, handling consistency, and actual performance from pickup to destination. We build contingency and re-routing logic so operations can intervene when thresholds are approached, supported by integrated and continuous monitoring. Carrier and airport assessments confirm alignment to SOPs, GDP expectations, and quality requirements, with documentation of protocols and lane qualification reports support your regulatory teams in their filings. The result is a qualified route network that is scalable and ready for clinical expansion or commercialization.

Qualified lanes offer predictability while maintaining the flexibility to adapt to demand and seasonality. Your teams gain confidence, knowing that anticipated variance due to transit times or environmental conditions are within documented limits, and as you open new sites or countries, we replicate and adapt the method to expand your network quickly. The documentation aligns with regulatory expectations, reducing the burden on reviewers. Over time, lane performance data feeds continuous improvement and informs refresh schedules, allowing your network to stay resilient while programs accelerate.

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Demonstrate that your pack-out protects payloads under real-world stress

Shipping System and Packaging Performance Qualification proves your shipping system, accessories, secondary packaging, and other pack-out configuration can successfully maintain required temperatures and withstand physical stress across defined durations. We test cryogenic, ultra-cold, refrigerated, and controlled room temperature bands with payloads and pack-out configurations that mirror actual use. Thermal and physical protocols are aligned with recognized industry standards and regulatory expectations. Testing incorporates worst-case profiles, shock and vibration exposure, and handling scenarios that simulate real-world challenges. Continuous monitoring captures data and events, providing documented evidence that controls work as intended. Acceptance criteria are established in advance in support of pass/fail decisions to be submitted with regulatory filings for both primary (intended) pack-out and secondary (backup) alternatives for if any supply disruptions occur.

A qualified shipping system and pack-out reduces variability and offers compliance and repeatability. It also provides quality and regulatory teams with the evidence they need to justify controls and backup/contingency plans. As product attributes, volumes, or destinations evolve, we can update the qualification to keep pace of where you’re going. This same methodology applies to bridging studies when you optimize packaging or accessories over time. A robust and intentional shipping system and packaging performance qualification approach is how you keep your packaging strategy aligned with clinical and commercial realities.

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Purpose-built hardware when your program requires unique, engineered solutions

While Consulting and Advisory Services focus on risk mitigation and proactive qualifications, some programs need custom packaging or accessories to achieve specific performance targets. Our expert teams design and engineer shippers, inserts, racks, indicators, and other secondary packaging and accessories that fit your payload dimensions, process, and operational constraints. We prototype with rapid iteration, verify form, fit, and function, and validate performance against agreed upon criteria. Designs consider key operational parameters like manufacturability, cleaning, labeling, and GMP handling. When appropriate, we can also coordinate bridging qualifications to ensure new designs transition seamlessly into regulated use.

Custom packaging and accessories extend your control strategy when standard operations can’t meet unique constraints. By pairing consulting insights with engineered solutions, you accelerate timelines and avoid fragmented vendor management. Designs are purpose-built with quality, cleaning, and handling in mind to streamline adoption. Where regulatory evidence is required, we plan qualification and bridging studies to maintain compliance. This collaboration keeps your hardware synced with lane strategies and system qualifications. It’s a pragmatic path that moves from requirements to manufactured reality with alignment against the broader end-to-end supply chain platform specific to your product and program.

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Navigate Complexity with Confidence

Pre-clinical development involves critical decisions that impact timelines, budgets, and regulatory outcomes. Cryoport Systems’ Consulting and Advisory Services provide strategic insights that help you plan for scalability and compliance, mitigating risks well in advance. Our experts collaborate with your team to perform strategic risk assessments and select optimal shipping lanes, helping you anticipate regulatory requirements. By leveraging our experience across thousands of programs (and more than a million successful shipments), you gain a partner who understands the nuances of cell and gene therapy logistics. With Cryoport Systems, you gain the insight required to make informed decisions that accelerate progress and reduce uncertainty.

• Risk-based logistics planning
• Regulatory readiness support
• Packaging performance qualification
• Custom packaging and accessory development
• Insights from global program experience

Expert guidance during pre-clinical development can significantly influence the success of your program. Cryoport Systems offers the knowledge and experience needed to align your processes now with future phases, reducing risk and improving efficiency. By working hand-in-hand with your team, we help you make decisions today that support the long-term goals and regulatory compliance for tomorrow. This level of partnership ensures that your program is positioned for success from the very beginning.

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Navigate Regulatory and Operational Complexity

Phase I introduces new layers of complexity, from regulatory requirements to multi-site coordination. Cryoport Systems’ consulting and advisory services provide strategic insights to help you plan for scalability, compliance, and risk mitigation. Our experts collaborate with your team to proactively mitigate common risks, select optimal shipping lanes, and anticipate regulatory expectations. We also deliver FDA-required shipping risk assessments, lane qualifications, and packaging validations to pre-clear your commercial runway.

• Risk-based logistics planning
• FDA-required risk assessments and lane qualifications
• Packaging validation for IND readiness
• Insights from global program experience

Phase I is where regulatory expectations begin to shape your operational reality. Cryoport Systems helps you navigate this complexity through proactive planning and expert guidance. Our Consulting and Advisory Services reduce uncertainty and prevent compliance gaps, positioning your program for smooth progression into later phases. By leveraging our experience gained across thousands of advanced therapy programs and more than a million successful deliveries, you gain a partner who understands the nuances of early-phase logistics and delivers solutions tailored to your needs.

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Navigate Complexity and Prepare for Commercial Expansion

Phase II trials are where operational complexity accelerates. Sponsors must manage larger patient populations, multiple geographies, and evolving regulatory expectations, all while preparing for Phase III and commercialization. Cryoport Systems provides Consulting and Advisory Services that go beyond logistics planning. Our experts help you design standardized processes with fully qualified shipping lanes as routes grow more complex and implement risk-based strategies that anticipate future scale. We deliver FDA-required risk assessments, packaging validations, and compliance frameworks that eliminate surprises during audits. By embedding scalability and global readiness into your process now, you avoid costly rework and delays later.

• Risk-based lane qualification for international and complex routes
• Packaging validation aligned with global regulatory standards
• Commercial runway planning and compliance readiness
• Strategic insight from thousands of advanced therapy programs

Phase II is focused on managing today’s complexity while building the foundation for tomorrow’s success. Cryoport Systems helps you anticipate challenges before they arise, ensuring your supply chain is ready for global scale and regulatory scrutiny. Our advisory services reduce operational burden and streamline decision making while providing confidence that every process meets the highest standards. By partnering with Cryoport Systems, you gain a roadmap for seamless progression into Phase III and commercialization, moving your program forward with clarity and precision.

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Expert guidance to navigate complexity and ensure compliance

Phase III trials introduce regulatory and operational challenges that require expert guidance. Cryoport Systems provides Consulting and Advisory Services designed to align your supply chain strategy with global compliance standards and commercial readiness. Our experts collaborate with your team to develop risk mitigation plans and continuity strategies that anticipate future needs. By embedding these practices early, sponsors avoid costly rework and maintain momentum toward BLA approval. Our advisory services extend beyond logistics, offering insights into regulatory requirements, import/export compliance, and best practices for global scalability. This proactive approach ensures that your supply chain remains resilient, compliant, and ready for commercialization.

• Risk-based lane qualification for international and complex routes
• Packaging validation aligned with global regulatory standards
• Commercial runway planning and compliance readiness
• Strategic insight from hundreds of advanced therapy clinical trials

Consulting and Advisory Services are essential for navigating the complexity of Phase III trials. Cryoport Systems provides the expertise and foresight to keep your program on track and compliant. Our solutions reduce uncertainty, mitigate risk, and create a clear path to commercialization. By partnering with us, you gain confidence that every decision supports long-term success.

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Expert guidance to navigate global complexity and ensure compliance

Commercial distribution introduces regulatory and operational challenges that require expert guidance. Cryoport Systems provides Consulting and Advisory Services designed to align your supply chain strategy with global compliance standards and market readiness. Our experts collaborate with your team to develop risk mitigation plans, shipping lane qualifications as new lanes open to support patients in expanding geographies, and continuity strategies that anticipate future needs. By embedding these practices early, sponsors avoid costly disruptions and maintain momentum toward patient delivery. This proactive approach ensures that your supply chain remains resilient, compliant, and ready for expansion as your patient populations grow worldwide.

• Shipping risk assessments to proactively mitigate risk in your expansion strategy
• Shipping lane qualifications to plan for geographical expansion of patient populations
• Commercial runway planning and compliance readiness
• Import/export expertise for international distribution
• Strategic insight from hundreds of advanced therapy clinical trials

Consulting and advisory services are essential for navigating the complexity of commercial distribution. Cryoport Systems provides the expertise and foresight to help you proactively plan for the growth and demands of your commercial program. Our solutions reduce uncertainty and mitigate risk, creating a clear path to global patient access for commercialized therapeutics.

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