Clinical Supply Regulation Resources

  1. What Does 2025 Hold For Pharma? 1/17/2025

    Look at what’s in store for pharma and life science in 2025. While we see many recurring themes, 2025 promises to be filled with unexpected — and possibly unprecedented — developments.

  2. Building Robust Clinical Supply Chains To Support Global Trials

    Ensuring drugs reach patients at the right time and place is crucial. Review key areas to consider as you build a robust clinical supply chain that supports global trials effectively and efficiently.

  3. 5 Common Clinical Supply Chain Speedbumps

    Clinical trials can be very complex. Discover the need to connect planning and oversight from sourcing to shipping, along with mastering requirements such as cold chain, border slowdowns, and data privacy.

  4. Understanding Post-BREXIT Regulatory Changes Impacting the Clinical Trial Supply Chain

    With many BREXIT provisions now in effect and more to come, supply chains serving clinical trials in the UK and/or EU member states must navigate a complex web of new regulations.

  5. Speed To Market – API Large-Scale Commercial Manufacturing 1/20/2022

    Learn how a top 20 US-based pharma company achieved more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection with the help of a CMO partner.

  6. Overcome Vaccine Development Complexities With The Right Supply Chain Partner 7/5/2022

    Explore the challenges impacting clinical supply chains and solutions to overcome these complexities, and understand why it is crucial to pick the right supply chain provider for vaccine storage and distribution.

  7. Cut Through Complexity, Gain Speed, And Get Your Drug To Patients ASAP

    Discover top challenges that emerging biologics face, packaging containment offerings and services that help mitigate risks, and ways to reduce obstacles that slow development.

  8. Is Your Clinical Supply Strategy Ready For EU CTR? 3/3/2022

    One of the most significant changes in the new EU regulation is Annex VI, which covers changes in the labelling requirements for investigational medical products (IMPs). So, what are the implications of these changes and how will they affect outer immediate packaging? 

  9. Leveraging The Bolar Exemption To Accelerate Market Access 3/17/2023

    Gain insight into the changing comparator sourcing landscape, focusing specifically on the instrumental role the Bolar exemption plays in the shift away from dependence on innovators for clinical supplies.

  10. Clinical Trial Logistics Provider Of The Year

    How can you utilize state-of-the-art GMP-compliant depot networks and logistics hubs to maintain product quality and safety standards for complex therapies?