Clinical Supply Regulatory Solutions

1. Go Beyond Orchestration: Delivering Advanced Therapy Lifelines

   Advanced treatments such as cell and gene therapies require sophisticated logistics to ensure product quality and efficacy. Explore the comprehensive solutions to support your therapy product through clinical and commercial.

2. An Introductory Guide To Clinical EU Qualified Person (QP) Services 10/3/2022

   PCI's team of qualified persons assume responsibility for all stages of the process, safeguarding patients including the audit of the supply chain for GMP compliance in addition to certification of products for use in clinical trials.

3. Frozen Packaging Solutions 6/21/2023

   Delve into how this partner's scalable packaging services for logistics support can achieve higher operational efficiency and lower quality and safety risks.

4. Proven Vial Containment That Scales From R&D To Commercial 2/20/2024

   Speed up your time to market and reduce your risk of selecting individual components that may not work well together by choosing the Ready Pack containment solution.

5. What Does It Take To Guide A Combination Product Down The Path To Regulatory Submission?

   As one pharmaceutical company learned, it takes support from the right partner to create an on-body device that can safely and reliably deliver their medicine—while empowering patients to take control of their own health.

6. Manufacturing Science & Technology (MS&T) And Supply Chain 4/27/2022

   At Kymanox, the Manufacturing Science & Technology (MS&T) and Supply Chain team, with its global experience in the biopharmaceutical and medical device industries, provides support for all product development phases from early clinical to post-commercial life cycle management.

7. The Future Of Glass Packaging Is Here

   Review the potential of Corning Valor® Glass to optimize the fill/finish process and reduce total cost of quality as well as overall manufacturing cost.

8. Cell And Gene Solutions To Power Your Success 9/19/2023

   The number of CGTs advancing toward clinical trials and commercialization is increasing, making it crucial for sponsors to find innovative solutions and leverage industry expertise to maintain a competitive edge.

9. Global End-To-End Solutions 4/27/2023

   Explore the benefits of a best-in-class Quality Management System, a global GMP Depot Network, Direct-to/From-Patient, Home Healthcare nursing services, and industry-leading expertise all under one single-source provider.

10. Centralize Your Labeling Workflow Management 12/16/2022

    TransPerfect Life Sciences supports clinical supply teams with an end-to-end labeling process that ensures compliance and reduces timelines to speed up regulatory approvals.