Thought Leadership

Journal Article

How Does the Shift to Early-Stage M&A Change Due Diligence?

The life sciences industry is shifting its dealmaking focus from high-cost acquisitions to smaller and more targeted deals. Even big pharmaceutical companies are moving away from mega mergers, which are a huge undertaking, and switching toward early-stage assets and smaller deals that allow them to manage risks and large investments.
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Journal Article

eCTD v4.0: A Look at 2025 and Beyond

The eCTD v4.0 standard has been available to be used for submissions to any ICH-participating regulatory agency since 2015, when it reached Step 4 in the International Council on Harmonisation (ICH) process. However, 10 years later, only Japan and the US have begun optional use of the new version.
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