Clinical Supply Packaging Resources

  1. IMP Labeling: EU CTR Transition Considerations 6/26/2023

    Review current requirements as outlined by the EU Clinical Trial Regulation, supporting guidance, and three key considerations when planning IMP labeling activities for ongoing studies.

  2. 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.

  3. Strategies To Achieve Labeling Harmonization Amid A Legal Entity Change 3/9/2023

    A strong labeling team is vital to ensure successful navigation of the legal entity change process, including developing a timeline, executing data transfers, and mitigating compliance risks.

  4. 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.

  5. A Risk-Based Approach To Injectable Combination Product Development 3/14/2023

    Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.

  6. GxP Inventory Enhances Supply Chain For Global Specialty Biotech Firm 8/15/2023

    Discover how the simplification and digitization of clinical supply chain operations enhanced transparency, lowered risks and expenses, and optimized efficiency.

  7. Overcoming Challenges In Cell And Gene Therapy Containment

    Review the hurdles that can slow your time to market, including the challenges in packaging high-value therapies and solutions to help you mitigate risk and simplify the journey.

  8. Packaging And Containment: Get Your Products To Market Faster

    Learn more about why focusing on packaging solutions early on can keep development on track, help you meet milestones, and get your product to market faster.

  9. Gain Confidence In Clinical Trial Outcomes

    Delve into the ways that smart packaging integrations within clinical trial strategies can improve adherence to dosing protocols and provide a comprehensive understanding of a patient’s exposure.

  10. Outsourcing Your Highly Potent Oncology Drug Product 4/6/2023

    Precision oncology treatments require specialized manufacturing and packaging, leading companies to outsource production. Assessing a CDMO’s highly potent processing capabilities is critical.