Thought Leadership
Blog & Article
- 27th May 2025
Journal Article
This article assesses some of the most notable clinical developments in recent years, where the next generation of research is likely to be heading in the coming years, how the regulatory authorities are responding to these advances, and how these developments and regulatory proposals are likely to impact patient access.
Journal Article
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.
White Paper
Growing regulatory complexity and mounting cost pressures mean that biopharmaceutical companies can struggle to sustain post-launch product revenue streams in today’s hyper-competitive global markets. More than ever, organizations are looking to strategically outsource the regulatory lifecycle management of their established products to help manage compliance risk and reduce costs, freeing up key internal personnel to focus on strategic projects.
