Consulting Services
Consulting Services to Unlock the Full Potential of Your Supply Chain
Expert guidance and customized solutions for life sciences logistics excellence
Cryoport Systems’ Consulting Services are designed to provide life sciences organizations with unparalleled expertise and support across their temperature-controlled supply chain. Our team of industry-leading experts partners with you to create high-quality, compliant solutions that address complex supply chain challenges, streamline clinical trial management, and mitigate risks at every stage.
Our consulting services encompass a comprehensive range of solutions, including shipping system qualification, packaging performance validation, regulatory and trade support, custom documentation and training, and more. With a focus on flexibility, scalability, and compliance, we provide the strategic insights and hands-on assistance you need to optimize your supply chain, reduce risks, and achieve your operational objectives with confidence.
Comprehensive Consulting Services Tailored to Your Needs
Explore our specialized, risk-mitigating solutions for every stage of your supply chain
Cryoport Systems offers a wide range of consulting services designed to support life sciences organizations at every phase of their product lifecycle. Whether you are navigating pre-clinical phases, advancing through clinical trials, or preparing for commercialization, our consulting services are tailored to meet your unique needs and ensure the success of your vital, life-saving therapies. Our dedicated team of experts collaborates with you to develop customized strategies and solutions that address your specific challenges and goals. From regulatory compliance to packaging performance, we provide the insights and tools necessary to optimize your supply chain and ensure the safe, efficient delivery of your valuable therapies.
Shipping Risk Assessments and Shipping Lane Qualification
Shipping risk assessments and lane qualifications are crucial for ensuring the safe and efficient transport of temperature-sensitive products. Our Consulting Services offer thorough risk assessments that identify potential threats to product integrity during transit. By leveraging our decades of experience and in-depth understanding of these risks, we can implement strategies to proactively mitigate any roadblocks, ensuring your valuable therapies reach their destination without compromise.
Our shipping lane qualifications provide an in-depth analysis of transportation routes to ensure they meet stringent standards. By evaluating factors such as climate conditions, handling procedures, and transit times, we can recommend optimal shipping lanes that preserve product quality. This process includes rigorous testing and validation to confirm that the chosen lanes can maintain the required temperature conditions throughout the journey.
Cryoport Systems’ expertise in risk assessment and lane qualification helps clients navigate the complexities of global logistics. Our team leverages our decades of historical and robust Cryoportal® 2 data alongside advanced technologies and industry knowledge to deliver tailored solutions that minimize risks and enhance the reliability of your supply chain. With our support, you can confidently transport your temperature-sensitive products across the globe.
Learn More about Shipping Risk Assessments & Lane Qualifications
Comprehensive Shipping System and Packaging Performance Qualification
Cryoport Systems provides comprehensive shipping system and packaging performance qualifications to ensure the integrity of temperature-sensitive products. Our consulting services include evaluating transportation, handling, and distribution processes, ensuring that packaging and shipping systems meet the highest standards of performance and reliability. This rigorous testing process is essential for strengthening your supply chain and maintaining product quality.
Our performance qualification services include physical, thermal, and custom testing to quantify and manage packaging, logistics, and shipper risk. We develop customized protocols based on your unique supply chain requirements, ensuring that our solutions align with your specific needs. Our packaging validation and testing services adhere to industry standards such as IATA, ISTA, and ASTM, providing reliable and accurate results.
Cryoport Systems’ Validation Engineers create detailed qualification protocols and reports that support regulatory compliance and quality assurance. Our comprehensive approach ensures consistency across all Cryoport Systems facilities, providing a streamlined and reliable process for our clients. With our expertise in shipping system and packaging performance qualification, you can achieve greater confidence in your supply chain operations.
Learn More about Shipping System and Packaging Performance Qualification
Custom Temperature-Sensitive Packaging and Accessory Development
Cryoport Systems specializes in developing custom packaging solutions tailored to the unique needs of temperature-sensitive products. Our team works hand-in-hand with clients to design packaging that ensures product integrity from origin to destination. This includes creating innovative solutions that address specific challenges related to temperature control, handling, and regulatory compliance. In fact, the Cryoport Elite® Shipping System for dry ice shipments at -60° to -80°C evolved from this service.
Our packaging development services also include the design and production of custom accessories that enhance the performance of your shipping systems. These accessories are engineered to provide additional protection, improve handling, and streamline the shipping process. By integrating these custom components, we can offer comprehensive solutions that meet the highest standards of safety and efficiency.
Cryoport Systems’ commitment to innovation and quality in packaging development ensures that your products are protected throughout the supply chain. Our custom solutions are designed to meet the rigorous demands of the life sciences industry, providing peace of mind and reliability for every shipment. Partner with us to create packaging that delivers unparalleled protection and performance for your temperature-sensitive therapies.
Global Regulatory and Trade Services
Navigating the complexities of international shipping regulations is a critical challenge for life sciences organizations. Cryoport Systems’ Global Regulatory and Trade Services provide the expertise needed to ensure compliance with global shipping standards. Our team guides clients through the regulatory landscape, offering support for obtaining necessary permits and certificates, and ensuring that shipments meet all legal requirements.
Our services include the evaluation of international shipping lanes, customized training sessions, and timely support for challenging shipments. By addressing the specific regulatory requirements of each destination, we help clients avoid delays and mitigate compliance risks. Our thorough understanding of global trade regulations enables us to provide valuable insights and practical solutions for international logistics.
Cryoport Systems’ Global Regulatory and Trade Services ensure the safe and efficient transport of temperature-sensitive materials and products across borders. With over two decades of experience, our team offers timely and relevant advice to help clients navigate complex multi-national supply chain risks. Lean on our decades of experience and track record of success to achieve seamless international shipping and maintain compliance with global standards.
Data Services
Cryoport Systems’ Data Services offer clients comprehensive insights into their supply chain operations. Our advanced data analytics capabilities provide near real-time tracking and monitoring of shipments, enabling you to make informed decisions and quickly address any issues that arise. This level of visibility is crucial for maintaining the integrity of temperature-sensitive products during transit.
Our data services include detailed reporting and analytics that help clients understand and optimize their shipping processes. By analyzing data on temperature conditions, transit times, and handling procedures, we can identify areas for improvement and implement strategies to enhance efficiency and reliability. This data-driven approach ensures that your supply chain operates at peak performance.
Cryoport Systems’ Data Services also support regulatory compliance and quality assurance efforts. Our comprehensive reports provide the documentation needed for audits and regulatory submissions, demonstrating adherence to industry standards and best practices. With our data services, you can achieve greater transparency, accountability, and control over your supply chain operations.
Custom Documentation and Training
Cryoport Systems offers customized documentation and training services to support the efficient handling and management of temperature-sensitive products. Our documentation development services assist with site documentation, shipment management, and risk mitigation, providing clear and comprehensive resources for your team. Customized documentation is essential for new clinical trials, product packaging updates, and commercial launch preparation.
Our training services offer tailored guidance for all steps in handling Cryoport Systems’ shippers with client-specific products. We provide flexible training options, including in-person sessions, pre-recorded videos, and live web training. Our experts develop custom manuals and standard operating procedures that ensure total understanding of our processes and services, enhancing compliance and operational efficiency.
Cryoport Systems’ documentation and training services help de-risk clinical trials and improve the consistency of your supply chain operations. By providing clear, customized resources and expert training, we support your team in maintaining the highest standards of quality and compliance. Partner with us to achieve greater confidence and reliability in your temperature-controlled logistics.
Unlock Industry Expertise
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Interview with Mike Dybicz, Cryoport Systems’ SVP ＆ CPDO
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Cryoport Elite® Shipping System: Industry-leading Advanced Therapy Support
The life sciences industry requires a robust shipping system that can handle the risks associated with transporting high-value commodities such as advanced therapies…
Expert Consulting for Every Phase of Development
Tailored support for every stage of your journey, pre-clinical to commercial
At Cryoport Systems, we understand the intricacies of the life sciences industry and the critical importance of maintaining the integrity of your products. Our Consulting Services are designed to support clients at every phase of their clinical trials and commercial operations. Our team of industry experts offers customized solutions to meet the unique needs of Contract Research Organizations (CROs) and biopharma companies. Whether you are in the early stages of research or approaching commercialization, our comprehensive consulting services help you navigate the complexities of the temperature-controlled supply chain.
Consulting Services to Support Pre-Clinical INDs
Cryoport Systems provides essential consulting support for companies in the pre-clinical investigational new drug (IND) phase, helping to streamline early processes and mitigate risks before they escalate. Our consulting services offer thorough assessments and customized solutions to identify best practices and address potential challenges in the temperature-controlled supply chain, and our team of experts works closely with clients to ensure smooth operations from the outset.
Cryoport Systems can streamline the start of your pre-clinical processes with our assessment services that help to identify best practices and risk-mitigating transport solutions before challenges arise within the supply chain. Our pre-clinical consulting services include shipping risk assessments, shipping lane studies, and shipper/package qualifications. These evaluations help identify and mitigate potential risks, ensuring that transportation routes and packaging systems are up to standard. By addressing these issues early, we help clients maintain the integrity of their products and compliance with regulatory requirements.
In addition to these assessments, Cryoport Systems provides custom packaging and accessory development tailored to the unique needs of the pre-clinical phase. Our innovative solutions ensure that products are protected throughout the transport process. We also develop custom documentation to support site operations and ensure consistent handling of Cryoport Systems’ shippers. Our training and onboarding services further ensure that your team is fully prepared to handle our shipping systems effectively. With our comprehensive support, clients can confidently advance their pre-clinical studies and prepare for the next phases of development, maintaining operational efficiency and regulatory compliance.
Consulting Services to Support Phase I
Cryoport Systems provides comprehensive support for companies in Phase I of their clinical trials, assisting with discovering a therapy’s viability. Our consulting services include thorough assessments, validations, and training procedures that maintain compliance standards and ensure the safe transport of temperature-sensitive products. Our team of experts works closely with clients to develop customized solutions that meet their unique needs.
Cryoport Systems supplies certainty to your Phase I trial through comprehensive shipping risk assessments, shipping lane validations, and shipper/package qualifications. These assessments help identify potential risks and ensure that transportation routes and packaging systems meet stringent standards. By implementing effective risk mitigation strategies, we help clients maintain product integrity and compliance throughout the supply chain, addressing potential challenges before they arise.
Additionally, Cryoport Systems offers custom packaging and accessory development to support the safe transport of products from the facility to the patient’s bedside. Our innovative solutions address specific challenges related to temperature control and handling, ensuring that products remain protected during transit. Our services also include custom documentation creation and training/onboarding programs, tailored to the specific needs of Phase I trials. With our comprehensive support, clients can confidently navigate the complexities of Phase I clinical trials, maintaining operational efficiency and regulatory compliance.
Consulting Services to Support Phase II
Cryoport Systems provides extensive support for companies in Phase II of their clinical trials, assisting with discovering a therapy’s viability and preparing for commercialization. Our consulting services include detailed assessments, validations, and training procedures that ensure compliance and enhance the safety and reliability of the supply chain. Our team of industry experts works closely with clients to develop tailored solutions that meet their specific needs.
During Phase II, Cryoport Systems supplies certainty to your trial through comprehensive shipping risk assessments, shipping lane validations, and optional shipper/package qualifications based on Phase I outcomes. These evaluations help identify potential risks and ensure that transportation routes and packaging systems meet stringent standards. By implementing effective risk mitigation strategies, we assist clients in maintaining product integrity and compliance throughout the supply chain, addressing any challenges that might have arisen in earlier phases.
Cryoport Systems also offers custom packaging and accessory development to support the safe transport of products. Our innovative solutions tackle specific challenges related to temperature control and handling, ensuring that products remain protected during transit. Our services include custom documentation creation and training/onboarding programs, tailored to the needs of Phase II trials. Additionally, we offer global regulatory and trade services if clients are expanding internationally, and we help start planning data services to support the upcoming phases. With our comprehensive support, clients can confidently navigate the complexities of Phase II clinical trials and prepare for commercialization.
Consulting Services to Support Phase III
Cryoport Systems provides critical support for companies in Phase III of their clinical trials, assisting with commercialization preparation and ensuring supply chain integrity. Our consulting services include comprehensive assessments, validations, and qualifications that maintain compliance standards and support the packaging and shipment of lifesaving therapies. Our team of industry experts works closely with clients to develop tailored solutions that meet their specific needs.
With commercialization on the horizon, complete certainty in your supply chain is crucial during Phase III. Cryoport Systems’ assessments, validations, and qualifications can assist with instituting compliance standards that will support the packaging and shipment of your lifesaving therapies. Our consulting services include shipping risk assessments, shipping lane validations, and shipper/package qualifications, all of which are critical for FDA requirements and best practices. These evaluations help identify potential risks and ensure that transportation routes and packaging systems meet stringent standards. By implementing effective risk mitigation strategies, we help clients maintain product integrity and compliance throughout the supply chain.
Cryoport Systems also offers custom packaging and accessory development to support the safe transport of products. Our innovative solutions address specific challenges related to temperature control and handling, ensuring that products remain protected during transit. Our services include custom documentation creation, training/onboarding programs, and global regulatory and trade services to assist with international expansions. Additionally, our data services provide comprehensive support for managing and analyzing supply chain data. With our extensive support, clients can confidently navigate the complexities of Phase III clinical trials and prepare for a successful commercial launch.
Consulting Services to Support Pre-Commercial BLAs
On the cusp of commercialization, maintaining quality procedures in your supply chain is key. Cryoport Systems provides essential support for companies preparing for Biologics License Applications (BLAs), ensuring a seamless transition to the market. Our consulting services include comprehensive assessments, validations, and customized solutions that maintain compliance standards and ensure the integrity of temperature-sensitive products. Our team of industry experts works closely with clients to develop tailored strategies that meet their specific needs.
Cryoport Systems offers extensive data services, shipping risk assessments, and shipping lane validations to help clients prepare for the commercial stage. These evaluations identify potential risks and ensure that transportation routes and packaging systems adhere to stringent standards. By implementing effective risk mitigation strategies, we help clients maintain product integrity and compliance throughout the supply chain, providing certainty in pre-commercial operations.
Our pre-commercial consulting services also encompass custom packaging and accessory design, which is crucial for ensuring that packaging meets Good Manufacturing Practice (GMP) standards, including labels, languages, spacing, and payload protection. Additionally, we offer custom documentation creation, training/onboarding programs, and global regulatory and trade services to support international operations. Our comprehensive data services are particularly important for preparing and managing supply chain data, enabling clients to confidently navigate the complexities of pre-commercial BLAs and ensure a successful market launch.
Consulting Services to Support Commercialized Biotherapeutics
Cryoport Systems offers specialized consulting services designed to support biotherapeutic companies through the critical stages of commercialization. Achieving commercial approval is a significant milestone that demands rigorous safety measures and tailored solutions. Our consulting services provide comprehensive support, beginning with shipping risk assessment and shipping lane validation to optimize logistics and mitigate potential risks. We ensure the integrity of shipments through meticulous shipper and package qualification, adhering to global standards for secure transportation.
In addition to logistical support, we specialize in custom packaging and accessory design, tailored to protect the integrity of temperature-sensitive products during transit. Our expertise extends to developing custom documentation that streamlines operations and maintains consistency in handling protocols. Complemented by robust training and onboarding programs, we empower your team to effectively manage integrated shipping systems and ensure seamless operations.
Navigating global markets requires expertise in regulatory compliance and strategic planning. Cryoport Systems offers global regulatory and trade services to facilitate expansions and ensure compliance with diverse regulatory frameworks. Our data services provide actionable insights and comprehensive reporting alongside on-the-shelf system integrations, enabling informed decision-making and proactive management of supply chain logistics. These integrated consulting services from Cryoport Systems empower biotherapeutic companies to navigate the complexities of commercialization confidently, ensuring operational efficiency and regulatory compliance from approval to successful market entry.
Consulting Services to Support CROs
Cryoport Systems’ Consulting Services provide strategic support for Contract Research Organizations (CROs), helping them overcome complex supply chain challenges and streamline clinical trial management. Our team works closely with CROs to create high-quality, compliant solutions that enhance the efficiency and reliability of their operations. With our extensive experience and industry-leading supply chain platform, we help CROs make informed decisions that protect the integrity of their temperature-sensitive products.
Key consulting services for CROs include comprehensive risk assessments and lane qualifications, ensuring that transportation routes meet the highest standards. By identifying potential risks and implementing mitigation strategies, we help CROs minimize disruptions and maintain product quality throughout the supply chain. Our advanced shipping systems, with built-in technologies and real-time tracking, provide maximum protection and flexibility.
Cryoport Systems also offers customized packaging and accessory development tailored to the specific needs of CROs. Our innovative solutions address the unique challenges of temperature-sensitive shipping, ensuring that products are protected from origin to destination. With our support, CROs can confidently manage their logistics and focus on advancing their projects with the knowledge that their supply chain solutions are in expert hands.
