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Mastering a Fragmented Global Regulatory Landscape
Strategies to navigate diverse regional requirements
The global regulatory environment has never been more fragmented. Across life sciences and pharmaceuticals, companies face an ever-changing patchwork of requirements, timelines and interpretations. These are differences that can delay approvals, increase costs, and strain compliance resources.
In this eBook, we unpack:
- How over 70% of global regulatory authorities still lack sufficient capability for efficacy and safety assessment.
- Why only 43% of countries across LATAM, APAC and MEA currently use reliance pathways, leading to duplicated work and delayed access.
- The heavy burden of thousands of post-approval change (PAC) submissions annually — each with different classifications, languages and timelines.
- How emerging modalities, such as cell and gene therapies, face inconsistent frameworks across the FDA, EMA and PMDA
- Actionable strategies for building flexible, region-sensitive regulatory models supported by analytics and intelligence
What you’ll gain:
✔ Proven approaches to manage fragmented regulatory pathways
✔ Practical insights on harmonization and reliance mechanisms
✔ Examples of how regulatory intelligence tools can support global teams
This eBook was built using Cortellis Regulatory Intelligence and Cortellis CMC Intelligence which provides real-time data, cross-regional comparisons and AI-powered insights to streamline compliance efforts.
