Guiding your journey through international trade: Unraveling the complex web of regulations in the supply chain of Advanced Therapies
Advanced therapy developers face numerous regulatory challenges when conducting clinical trials across the EMEA region. These challenges include variability and complexity in ethical, administrative, regulatory, and logistical (EARL) requirements, differences in timelines for regulatory and ethical approvals, and the evolving European Union regulatory environment.
One such company that aims to help navigate these challenges is Cryoport Systems. Based in the United States, Cryoport Systems provides a specialized cold chain logistics platform optimized for Advanced Therapy Medicinal Products (ATMPs) and cell and gene therapies.
Expert Guidance and Compliance
Cryoport Systems offers a range of services designed to ensure compliance with diverse regulatory and quality standards. Their Qualified Person (QP) services provide expert guidance and peace of mind that materials are always handled compliantly throughout their journey. The QPs, who are academically qualified in pharmacy, chemistry, or biology, work onsite within their facilities.
The QP services are relevant for both global clinical trials and scaling operations for commercialization. Cryoport Systems' QPs handle duties such as pass-through depot for urgent shipment requests, consulting services, EU QP audits, issuance of QP Declaration, certification of drug products, and importation of pharmaceutical products.
Streamlined Supply Chain
Cryoport Systems' services aim to establish a streamlined ATMP supply chain across the EMEA region, enabling life-saving work for manufacturers. Their shipping risk assessments inform personalized shipping lane validations for optimized and risk-mitigated transport.
The company's platform of solutions, including Consulting Services and Cryoportal® 2, enables the Outcome™ for ATMP manufacturers. Cryoportal® 2, Cryoport Systems' industry-leading logistics management system, provides near real-time data and a comprehensive look into shipment processes. It condenses shipment inventory, ordering, tracking, documents, and reporting into a single interface.
Regulatory Compliance
Cryoportal® 2 complies with 21 CFR Part 11 and ISPE GAMP, ensuring regulatory compliance during shipment tracking. The platform is offered in their EU locations, allowing for scalable support of ATMP supply chains through Cryoportal® 2.
Cryoport Systems offers Consulting Services, comprised of subject matter experts who stay updated on international regulatory requirements for customs clearance. This service is particularly useful for organizations that do not have an established QP on their team.
In summary, Cryoport Systems can help advanced therapy developers navigate the complex regulatory landscape of the EMEA region by providing end-to-end logistics and compliance support tailored to the needs of ATMP clinical trials. This assistance can help reduce delays and enhance trial efficiency across the region.
[1] Advanced Therapies Medicinal Products (ATMPs): Challenges in the EU Clinical Trials Landscape. (2020). Retrieved from www.cryoport.com/resources/white-papers/atmps-challenges-in-the-eu-clinical-trials-landscape
[2] Cryoport Systems Provides Comprehensive Solutions for ATMP Clinical Trials. (2021). Retrieved from www.cryoport.com/resources/white-papers/cryoport-systems-provides-comprehensive-solutions-for-atmp-clinical-trials
[3] UK Clinical Trial Regulations and Advanced Therapies. (2021). Retrieved from www.cryoport.com/resources/white-papers/uk-clinical-trial-regulations-and-advanced-therapies
[4] Harmonization of Clinical Trials in Europe: Challenges and Opportunities. (2020). Retrieved from www.cryoport.com/resources/white-papers/harmonization-of-clinical-trials-in-europe-challenges-and-opportunities
- Cryoport Systems' Qualified Person (QP) services offer expert guidance and compliance, ensuring materials for cell and gene therapies are always handled appropriately during clinical trials or commercialization processes.
- The company's shipping risk assessments and streamlined platform of solutions, including Cryoportal® 2, aim to create a seamless Advanced Therapy Medicinal Products (ATMP) supply chain across the EMEA region for ATMP manufacturers.
- Cryoportal® 2, in compliance with 21 CFR Part 11 and ISPE GAMP, provides regulatory adherence during shipment tracking, enabling scalable support for ATMP supply chains through its EU locations.
- Cryoport Systems' Consulting Services, manned by subject matter experts, provide valuable insights on international regulatory requirements, particularly for organizations without an established QP on their team, empowering them to navigate the complexities of health-and-wellness, medical-conditions, therapies-and-treatments, and biotech within the EMEA region.
