Halloran Insights

  1. CMC Roadmap: Considerations For Small Molecules, Recombinant Proteins 8/16/2024

    In this presentation, speakers guide viewers through essential questions and real-world scenarios, helping to craft a successful Regulatory CMC roadmap throughout the clinical development lifecycle.

  2. How, Why, And When To Apply For An Orphan Drug Application 8/16/2024

    Gain access to strategic insights for clinical trial sponsors on targeting an orphan drug designation and the logistical considerations involved in pursuing this path from the outset.

  3. Catching Up With Consulting — DIA 2024 Insights 7/12/2024

    Explore the insights and perspectives from the DIA 2024 Global Annual Meeting to stay informed on the latest advancements in clinical trials and regulatory landscapes shaping the pharmaceutical industry.

  4. How Regulatory CMC Experts Navigate Expedited Accelerated Approval Timelines 7/12/2024

    CMC experts stress that, despite adjusted timelines, stringent manufacturing and characterization requirements for product safety and quality remain, necessitating proactive planning to meet deliverables within the expedited approval period.

  5. The Quality Equation: 4 Essential Components To Enable Drug Development Success 6/18/2024

    In this episode, experts share their insights on the four essential components for achieving quality excellence in clinical trials.

  6. Inspection Readiness Methodology: Failure To Plan Is A Plan To Fail 6/18/2024

    Join us to learn how to stay inspection-ready throughout the clinical trial process and enhance your chances of market approval for your product.

  7. Raw Material Control For Biotechs (Part 2): Clinical Development Considerations 5/15/2024

    Take a deep dive into several strategies being used to enhance raw material control to facilitate successful regulatory submissions and commercialization efforts.

  8. Leadership Considerations To Enable Clinical Development Success 5/15/2024

    Explore several leadership examples that underscore the value of assembling the right expertise across organizations, facilitating successful outcomes, and cultivating a favorable track record for future investment opportunities.

  9. Success Planning For An Original NDA/BLA Submission 4/15/2024

    Experts in regulatory strategy, operations, and program leadership provide strategies for initiation triggers, team coordination, submission processes, and Electronic Submission Gateway (ESG).

  10. Should You Bring Your Trial Master File In-House? 4/15/2024

    Deciding whether to bring the TMF in-house or contract with a CRO depends on the sponsor's specific needs and resources, and it's important to consider the implications beforehand.