Navigating Your Path To Globalization: Untangling The Regulatory Maze Of The ATMP Supply Chain
In the highly modulated world of advanced therapy medicinal products (ATMPs), conducting clinical trials across the EMEA (Europe, the Middle East, and Africa) region requires a deep understanding of global trade and supply chain regulatory requirements. As operations scale to achieve commercialization, the required knowledge base to sustain an international temperature-controlled supply chain becomes more complex. For many advanced therapy developers, this rapid escalation feels as if the road to success has evolved into a maze of regulatory challenges too complicated and time-consuming to navigate on one's own.
Whether you’re planning a global clinical trial or scaling operations for commercialization, Cryoport Systems understands the critical importance of adhering to regulatory requirements for the success of your operation. With Cryoport Systems as your chosen provider, our team of industry experts will act as an extension of your team and utilize our platform of supply chain solutions to guide you through the complexities of the regulatory landscape for a sustained ATMP supply chain across the EMEA region.
Expert Assistance for Your Team with QP Services
The EU Clinical Trials Directive 2001/20/EC7 requires all drugs manufactured within the European Union to be certified by a Qualified Person (QP). A QP is a designated professional responsible for ensuring that each individual drug batch has “been manufactured and checked in compliance with the laws in force in the member state where certification takes place and in accordance with the requirements of the marketing authorization (MA) with good manufacturing practice (GMP)."1 While required for every manufacturer, not every organization has an established QP on their team who can navigate the standards and ensure compliance.
Cryoport Systems’ EU locations provide a Qualified Person (QP) to facilitate the oversight of import and release for clients to streamline this step in the regulatory process. These Cryoport Systems’ employees are academically qualified in pharmacy, chemistry, or biology and work onsite within our facilities. Our QPs are equipped to handle the necessary duties and uphold compliance standards, including:
- Pass-through depot for urgent shipment requests.
- Consulting services concerning regulatory requirements.
- EU QP audits of manufacturing and testing facilities.
- Issuance of QP Declaration.
- Certification of drug products.
- Importation of pharmaceutical products.
Our QP services support the beginning steps of transporting your irreplicable clinical and commercial samples across borders, offering expert guidance and peace of mind that your materials are always handled compliantly throughout their journey.
Navigating International Transport with Customs Clearance and Trade Services
Alongside expert QP services, our supply chain management capabilities extend to customized solutions for navigating the complexities of international logistics. Cryoport Systems’ Consulting Services team is comprised of subject matter experts (SMEs) who stay up to date on the latest international regulatory requirements. This allows our team to compliantly manage customs clearance of your drug products throughout the EMEA region, which includes the preparation and submission of required documentation, coordination with customs authorities, and management of any issues that may arise during the clearance process. Our proactive approach ensures that your shipments clear customs quickly and efficiently, minimizing delays and reducing the risk of product loss or damage.
In addition to customs clearance, our trade advisory services provide strategic guidance on international trade regulations and best practices. Our team will help you develop and implement effective trade strategies that optimize your supply chain operations and adhere to global trade laws. This level of personalization is unmatched in the life sciences industry and establishes a supply chain that upholds the specifications your project requires.
Personalized Assessments Supporting Risk Mitigation
The ability to actively mitigate risk is paramount to the ATMP supply chain, and our risk mitigation processes start even before your product is packaged for transport. Cryoport System’s Consulting Services offer valuable guidance through shipping risk assessments. These assessments include a detailed analysis of cross-carrier data on 800,000+ tracked shipments across various temperature bands, shipper types, and global lanes. This service is driven by quality processes developed over decades of supporting client regulatory submissions at all stages of clinical and commercial development.
Once evaluated, our team uses the shipping risk assessment to create a personalized shipping lane validation encompassing the most beneficial lane selections for your materials’ transport journey. This tailored review provides insights into the real-world viability of critical shipping lane assumptions and product related critical dependencies. Our protocol-driven lane validations assist in informing decisions regarding shipment lane/courier selection, handling, and package integrity while also qualifying shippers and payload systems. The risk assessment and shipping lane validations are a risk-mitigating combination to provide added certainty that your materials will be transported only via the best possible route.
Scalable Technology Unmatched in the Industry
Furthermore, Cryoport Systems’ established technology allows you to scale our support of your supply chain from our online system when you need it. Cryoportal® 2 is our industry-leading logistics management system that gives you a comprehensive look inside your materials’ shipment process. In conjunction with our Smartpak II® condition monitoring system, Cryoportal® 2 provides near real-time data about a shipment’s internal temperature, external temperature, orientation/tilt, location, and other metrics while maintaining compliance with 21 CFR Part 11 (Code of Federal Regulations) and ISPE GAMP (International Society for Pharmaceutical Engineering, Good Automated Manufacturing Practices).
Tracking the specifics of your shipments is one of many beneficial features of our logistics management system. Cryoportal® 2 condenses a shipment’s inventory, ordering, tracking, documents, and reporting into a single interface. With the Cryoportal® 2, you can:
- Oversee all order information such as user roles, profiles, contracts, commodities shipped, and more.
- Leverage data reports based on order history through the Customer Dashboard.
- Create new orders from existing templates or from scratch.
- Receive customized alerts, exception notices, and automated email notifications on your shipments to your account’s contact list.
- And more.
The robust usage of Cryoportal® 2 gives you the ability to tailor our support to your evolving needs, making Cryoport Systems your single provider with the ability to assist your supply chain operations from end-to-end.
Establishing a streamlined ATMP supply chain hinges on the proficiencies of a superior supply chain provider. Cryoport Systems’ knowledgeable team and platform of solutions Enable the Outcome™ for ATMP manufacturers so you can focus on your life-saving work while we handle the intricacies of a risk-free international supply chain across the EMEA region.