The Security You Can Trust in
Secondary Drug Packaging & Labeling
Secondary Packaging and Labeling that Protects Compliance and Timelines
GMP-controlled processes for clinical and commercial programs
Packaging and labeling are critical regulatory requirements that carry significant risk if handled incorrectly. Errors in labeling can lead to compliance violations and costly delays. Our secondary packaging and labeling services are designed to mitigate risks by delivering GMP-controlled processes that meet global standards. Every detail is documented, every label is verified, and every pack-out is prepared to protect overall integrity and compliance.
Cryoport Systems integrates packaging and labeling into our overall BioServices offering that handles full pick, pack, label, cart, and ship, which is further integrated into our connected supply chain that includes other key services like biostorage, cryopreservation of starting materials, logistics, and QP release. This approach reduces handoffs and ensures that every link in the supply chain aligns with quality systems. Whether you need support for early-phase clinical trials or large-scale commercial programs, our infrastructure adapts to your requirements and scales alongside your program’s progression.
Precision Processes that Protect Your Program
Reducing variability while meeting global standards
Secondary packaging and labeling of drug product requires accuracy and traceability, with validated compliance at every step. Our services combine GMP-controlled environments with validated workflows to deliver packaging that meets regulatory expectations and supports your operational goals. The result is a streamlined process that keeps timelines intact and compliance assured.
GMP-Compliant Packaging
Controlled environments for every product
Packaging must protect product integrity and meet strict regulatory requirements. Our facilities operate under GMP standards and maintain validated, temperature-controlled processes for every step of the workflow. Components are sourced from approved suppliers and verified for compliance before use. Packaging configurations are tailored to your product and your distribution plan, ensuring security and stability during transit. Every action is documented for full traceability, making audits straightforward and stress-free. You gain confidence that packaging supports both patient safety and regulatory compliance with quality built into every detail.
Packaging that meets the highest standards without compromise.
Our approach ensures that packaging is consistent and validated, fully GMP-compliant and meeting the needs of your unique drug product and program. We also can work with sponsors to develop custom packaging and accessories to ensure the most appropriate pack-out for your needs. When quality matters most, we deliver.
Accurate Labeling
Clarity that eliminates risk
Labeling errors can lead to serious consequences, from compliance violations to patient harm. Our labeling processes are designed to prevent those risks through rigorous checks and controlled workflows. Labels are verified for accuracy and clarity before application, and every step is documented for traceability. We manage language requirements, regulatory symbols, and variable data to ensure compliance across regions. This attention to detail reduces errors and protects timelines. You gain confidence that every label communicates exactly what it should. Accuracy becomes a safeguard, not a question mark.
Labels that protect compliance and patient safety.
Labeling is a critical control point, one that needs to be reliable and repeatable, handled within temperature-controlled and GMP-validated environments. Partnering with Cryoport Systems for labeling integrates these services seamlessly with biostorage, secondary packaging, and other BioServices as well as the greater end-to-end supply chain platform.
Integrated Supply Chain
Packaging connected to biostorage, logistics, and QP release
Managing packaging and/or labeling as a standalone process creates inefficiencies and risk. Our integrated model connects packaging and labeling with biostorage, shipping, and regulatory oversight under one system. This approach reduces handoffs and ensures every step aligns with your quality standards. Packaging is completed in GMP-controlled environments and prepared for immediate distribution alongside validated shipping systems. QP release and documentation are managed within the same workflow, eliminating delays and compliance gaps. You gain a streamlined process that supports your timelines and simplifies oversight.
One system for packaging, labeling, and compliance.
Integration of the full end-to-end supply chain from bench to bedside adds convenience, but also helps to mitigate risk. By consolidating services, you strengthen oversight and improve predictability. Your team spends less time managing fragmented vendors and can focus more of their time on advancing your program. Compliance becomes streamlined with better accountability at every stage, and scalability becomes a natural progression that is handled with ease.
Packaging Performance Qualification
Validated packaging that meets regulatory expectations
Packaging is a critical control point for compliance and product safety. Our shipping system and packaging performance qualification services validate that your packaging systems meet the requirements for your product and your distribution plan. We conduct rigorous testing under real-world conditions to confirm durability, temperature stability, and regulatory compliance. This process mitigates risk and ensures packaging performs as intended throughout the supply chain. Advanced therapies often require specialized configurations or accessories to maintain integrity and compliance. Our team designs and develops custom packaging systems that address these challenges without sacrificing quality or scalability. We work closely with your team to understand product specifications, regulatory requirements, and operational constraints. Solutions are validated for performance and integrated into your supply chain for seamless execution.
Packaging validated for performance and compliance.
Qualification of your pack-out is a guarantee of reliability as much as it’s a regulatory checkbox. Our packaging performance qualification services make that guarantee clear and documented in support of your regulatory filings. That means fewer surprises during audits, but also fewer risks during transit. When performance matters, we deliver.
Supporting Global Scalability
Capacity and coverage for every stage of development
As programs expand across geographies and move toward commercialization, packaging and labeling must scale without compromising quality. Our infrastructure is built for that challenge. We operate GMP-compliant facilities strategically located in the United States, Europe, and APAC, supported by the industry’s largest fully owned fleet of shipping systems. Packaging is completed and delivered with precision, whether you need support for a single study or a global program. This reach reduces transit times and simplifies coordination across regions. It also gives you confidence that scale will not introduce risk or variability. Wherever your science goes, our systems are ready to support it.
Your packaging delivered anywhere, without compromise.
Scalability is essential for growth, and we make it seamless. Our processes expand with your needs while maintaining the same standards that protect your program today. That means fewer disruptions and more confidence as you advance toward commercialization. Investors see a plan built for scale, and regulators see consistency across every site.
Ready to get started? Let’s talk!
Featured Resources
Video
Consulting and Advisory Services
Cryoport Systems consulting services has an ever expanding suite of solutions that are targeted to companies at all stages of clinical and commercial development across the life science industry. Our team tailor offerings to our clients’ needs, delivering the right solution at the right time and suited to product sensitivities, handling, storage and transport. From risk assessments to packaging performance…
Article
Scale Smarter: How Global Supply Chain Centers Amplify CGT Program Growth
Cell and gene therapy (CGT) programs are among the most complex and sensitive operations in the life sciences. From cryopreservation and biostorage to logistics and regulatory compliance, every step in the supply chain can influence product integrity, clinical timelines, and…
Video
Comprehensive, Integrated BioServices
BioServices from Cryoport Systems provide an end-to-end solution for biopharmaceutical companies conducting clinical trials and distributing advanced therapies. With decades of expertise in cell and gene therapy logistics, our team understands the critical nature of handling and transporting sensitive materials. Our global infrastructure…
