Clinical Supply Regulation Resources

  1. 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.

  2. Cold Chain Shipping Considerations: Understanding Passive Shippers

    Learn more about the design and performance of passive shippers and how different material and coolant configurations can impact the cost and efficacy of your shipping solution.

  3. How Direct-To-Patient Models Can Provide Clinical Supply Chains With An End-To-End Solution 9/20/2021

    Analyze the benefits and challenges of implementing direct-to-patient services in the clinical supply chain to help meet patient requirements, improve supply chain efficiency, and accelerate speed to market.

  4. 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.

  5. 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.

  6. Quality Assured: Bringing Life-Changing Therapies To Patients 1/12/2023

    Biopharmaceutical drug development remains a key trend, demanding specific expertise and capabilities when it comes to quality assurance. Explore four trends that matter in biologics for clinical trial supply.

  7. Reaching First-In-Human Trials Faster: Connect With The Right Partner

    Assessing outsourcing partners’ credentials in people, technology, supply chains, and integration will make all the difference as sponsors aim to streamline processes on the path to commercialization.

  8. 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.

  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. Benefits Of Electronic Labels: Investigational Medicinal Products 12/2/2022

    When a new therapeutic drug, medical device, vaccine, or other investigational medicinal product (IMP) is developed, learn why a label must be on its packaging that provides relevant and important information.