Compliance and Excellence
in Regulatory & QP Services
QP and Regulatory Services that Simplify Compliance
Expert oversight for every step of your clinical and commercial supply chain
Managing global requirements can quickly feel overwhelming, especially when programs span multiple regions and phases. Our Qualified Person (QP) and regulatory services remove that complexity by providing expert oversight and documented assurance that every process meets the standards required for release. From batch certification to audit readiness, we make compliance predictable instead of stressful. By partnering with Cryoport Systems, you gain confidence that your supply chain is aligned with regulatory expectations at every stage.
We combine deep regulatory expertise with integrated infrastructure to deliver an end-to-end supply chain platform solution that works across borders and scales with your program. Our QPs are fully authorized to certify product for release in the European Union (EU) and ensure adherence to GMP guidelines. We manage documentation, risk assessments, and quality checks so your team can focus on advancing your science. This approach reduces delays and prevents costly deviations, positioning your program for success as it moves into late-phase trials and commercialization. With Cryoport Systems as your single-vendor solution to your supply chain, compliance becomes a strength rather than a barrier to growth.
Compliance Built Into Every Process
Reducing risk while accelerating timelines
Regulatory oversight is often seen as a hurdle, but when managed correctly, you can navigate the course with ease. Our services integrate QP release and regulatory support into your full end-to-end supply chain so compliance is never an afterthought. As programs progress into later stages with multi-site, global trials and eventually into full commercialization worldwide, the complexity of managing regulatory requirements and import/export guidelines, QP release requirements, and country-specific nuances can quickly feel overwhelming. Partnering with Cryoport Systems means you gain immediate support and access to our global footprint, full supply chain platform of integrated solutions, consulting and advisory services to navigate risk assessments and lane qualifications for expanding territories, and QP services for release of drug product into the EU. Our services are built to flex and scale with your needs, adding resilience and confidence to your supply chain strategy from the start and within a single-vendor relationship backed by our track record of success that spans decades.
QP Release and Batch Certification
Authorized oversight for EU compliance
Releasing investigational medicinal products (IMPs) in the EU that have been manufactured and/or tested outside the EU requires certification by a Qualified Person, and the process must be precise. Our QPs are fully authorized and experienced in managing complex clinical and commercial programs in full compliance with European Directive 2001/83/EC Article 51 and Annex 16 of the EU Guidelines for GMP. They review documentation, verify GMP compliance (or equivalent), and certify batches for release without unnecessary delays. This oversight ensures your product moves forward without risk to patient safety or regulatory standing.
Certified for release with confidence and speed.
QP release is critical for EU programs, and we make it simple. Our team handles the details so your timelines stay intact. That means fewer surprises during audits and smoother transitions between phases. Your product reaches patients faster, and your team spends less time managing paperwork. When certification matters most, we deliver it.
Regulatory Documentation and Audit Support
Complete traceability for every requirement
Audits demand clarity and completeness, and missing documentation can lead to costly delays. Our systems provide full traceability for every step of your supply chain, including full Chain of Compliance® audit-ready data of every shipping system with equipment history and shipment history, including condition monitoring details for the entire shipping journey. We prepare and maintain records that meet global standards, making audits straightforward and stress-free. This transparency reduces risk and builds trust with regulators and partners. You gain confidence that your program is ready for inspection at any time. Compliance becomes a source of strength rather than uncertainty.
Documentation that makes audits predictable
Our QP services and consulting and advisory services can help you prepare for regulatory filings with FDA-required risk assessments, shipping lane qualifications, and packaging validations as well as help ensure commercial products are launched in accordance with global regulatory requirements. Audit readiness shouldn’t be a scramble. Our approach ensures records are complete and accessible so you can respond quickly and confidently, ensuring regulators see consistency and partners see reliability. When clarity matters, we deliver.
Integrated Quality Oversight
Industry-leading quality embedded across the supply chain
Quality is foundational to the supply chain, existing not in a single link of the chain but across the entire ecosystem. Our integrated model embeds quality oversight into everything we do, from kit production to sample management to biostorage and logistics. Every process is validated, monitored, and documented under GMP, GCP, GCLP, and GDP guidelines. We maintain ISO certifications (including ISO 9001, ISO 20387, and ISO 21973) that demonstrate quality at every level. This approach reduces variability and prevents issues before they occur, mitigating risk at every available turn. Our industry-leading approach to quality and compliance brings together the industry’s only validated decontamination protocols, robust equipment requalification processes, our proprietary Chain of Compliance® approach, and the Cryoportal® logistics management system for robust, audit-ready data that ensures the integrity of your temperature-controlled supply chain at every stage.
Quality built from start to finish.
Integrated oversight means fewer risks and smoother operations. Your team is able to focus on advancing programs as compliance becomes easier and scalability becomes a natural progression. Under our quality and compliance framework, you can demonstrate stability to investors and consistency to regulators.
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Featured Resources
Video
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