Discover how EMA and FDA are transforming from reviewers to data-platform operators—and how sponsors and writers must adapt to real-time evidence exchange and continuous review.

Explore how the EMA’s 2025 Real-World Evidence Framework is reshaping regulatory submissions—and what it means for medical writers navigating structured data and evolving reviewer expectations.

Explore the real costs, risks, and ROI of building versus buying an AI-powered regulatory documentation system—and why a hybrid approach often wins

Advancements in AI-driven technologies, especially generative AI, are reshaping industries at a rapid pace. While prompt engineering—crafting inputs to guide AI—has been a focal point, context engineering is emerging as a critical approach for creating AI systems that truly understand complex domains. This distinction is especially important in AI-enabled medical writing, where precision, compliance, and clarity are paramount.  In this blog, we’ll explore the key differences

Learn how Synterex helps biotechs turn regulatory uncertainty into advantage through expert strategy, automation, and AI-enabled efficiency.

In 2025, several major pharmaceutical companies — including MSD (Merck), AstraZeneca, and Eli Lilly — have scaled back or cancelled planned investments in the UK. Decisions have ranged from pausing vaccine-manufacturing expansions to abandoning research center projects.