INSIGHTS ON CELL & GENE REGULATORY ISSUES

• Addressing The Challenges And Opportunities In Gynecologic Cancer Research

  With investment in research on the rise, explore the challenges investigators face in patient identification, site selection and the ever-changing regulatory landscape in the available webinar.

• The Life Sciences’ Industry's First and Only - Advanced Therapy Shipper™ Product Line

  We not only guarantee your shipper has never contained non-human-based materials, we provide certification of conformance as well as unmatched traceability so you can have confidence that your irreplaceable samples will arrive intact and in line with even the newest regulatory guidance.

• The Regenerative Medicine Supply Chain: Anticipate New Compliance Standards Now Or Risk Falling Behind

  Regenerative medicine materials are inherently fragile and more at risk than other products during the supply chain process. While few industry-wide standards currently exist, the industry can expect new regulations in nine areas.

• Recognizing The Importance Of Your Data And Biological Material

  Cryoport understands that ensuring the quality and integrity of your shipment is of the utmost importance when transporting and storing materials that need to be maintained under exacting environmental conditions.

• Are You Complying With ISO 21973? General Requirements For Transportation Of Cells For Therapeutic Use

  ISO 21973 is the first standard to specifically address, in detail, the requirements for the cell and gene therapy supply chain. Understand the new requirements of ISO 21973, why it matters, and what steps developers should take to drive compliance.

• Cryoport Consulting Solutions

  Through Cryoport’s Consulting Solutions, you have access to the industry’s best technical resources in engineering, design and logistics. Delivering key business differentiators and risk mitigation processes, our experts support your distribution needs for critical materials, including research, clinical and commercial drug product materials.

• Global Regulatory & Trade Services Consulting

  Cryoport Trade Services Consulting team assists clients to help make this complex process seamless by collaboratively assessing the risks and processes involved to facilitate international trade.

• 3 Keys To Meeting Regulators’ Data Expectations

  To improve the actionability of data, pharma organizations can take the following three fundamental steps that will enhance their ability to leverage it to achieve quality and compliance goals.

• Post-Discovery Priorities: Streamlining Your Molecule’s Route To IND

  Four experts in post-discovery strategy answer questions about critical considerations that impact timelines and commercialization and share insights related to methodologies, robust platform process design, high-throughput automation technologies, optimized workflows, and lifecycle approaches.

• Quality Center Of Excellence

  As value chains extend around the globe, regulations evolve, and organizations feel the pressure to accelerate the speed at which they bring innovation to market; the need to maintain and optimize quality management systems has become more critical.