Clinical Supply Regulation Resources

  1. Advantages Of Robotic Aseptic Processing 10/6/2023

    Examine the robotic technologies poised to increase manufacturing flexibility and efficiency while minimizing risk when bringing biologics to market.

  2. 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.

  3. A Practical Packaging Components Checklist For Emerging Biotechs 6/20/2024

    A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.

  4. Specializing In Small And Early-Stage Partners, Not Just Small Batches 8/16/2023

    Many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.

  5. Distributing Clinical Supply In The EU For Compassionate Use Programs 12/21/2022

    Explore the logistical and distribution risk management factors that need to be considered when planning an EU Compassionate Use Program, especially when faced with COVID-19 closures and challenges.

  6. 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.

  7. 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.

  8. Comparator Sourcing: How And Why To Choose A Provider

    The right comparator sourcing strategy is critical. Review what sponsors need to consider when selecting the right provider in order to source the needed commercial products.

  9. Global Clinical Supply Solutions For Every Trial

    A reliable clinical supply chain strategy is as essential as a company’s discovery program. Seek a partner who can help guide a comprehensive  strategy and manage day-to-day activities.

  10. The Changing Dynamics Of The Pharma/Biotech Supply Chain – A Packaging And Clinical Supply Perspective 3/29/2021

    Perhaps more than any other industry, pharma and biotech have undergone radical change over the past year, as a result of the COVID-19 pandemic. From supply chain security and capacity to clinical trial operations and site auditing, almost every aspect has been affected. Experts explore how these trends are shaping the industry and offer an outlook.