Halloran Insights
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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.
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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.
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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.
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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.
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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.
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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.
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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).
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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.
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Preparing Now For FDA's START Program For Rare Disease Drug Developers
3/14/2024
Delve into this overview of the START pilot program, expectations to consider if you are applying to the program, and early preparation considerations.
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Bringing In Vitro Diagnostics To Market With Real-World Evidence
3/14/2024
Explore the potential of real-world evidence in enhancing the regulatory decision-making process to facilitate the market entry of IVDs.