Clinical Supply Regulatory Solutions

  1. 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.

  2. Scalable Manufacturing Of Sterile Drug Products 3/31/2023

    Discover comprehensive clinical to commercial scale manufacturing services that deliver true life-cycle management for sterile drug products that bring treatments to patients with efficiency and quality.

  3. SMART First Human Dose (FHD)

    A CDMO with the right team of experts can aid drug development, regulatory compliance, and clinical trial supply, accelerating timelines to first human dose clinical trials and the path to market.

  4. 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.

  5. 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.

  6. 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.