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When the Regulator Becomes the Data Platform: How 2025 Real-World Evidence (RWE) Initiatives Are Rewriting Regulatory Review
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.

Jeanette Towles
Nov 3, 2025


From Datasets to Disclosures: How the EU’s 2025 Real-World Evidence (RWE) Roadmap is Redefining Regulatory Writing
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.

Jeanette Towles
Nov 3, 2025


Build vs Buy for AI Tools in Regulatory Documentation: How to Make the Right Decision
Explore the real costs, risks, and ROI of building versus buying an AI-powered regulatory documentation system—and why a hybrid approach often wins

Jeanette Towles
Oct 29, 2025


Advancements in AI-Driven Technologies: Context Engineering in Clinical Trials
Understanding AI Technologies AI technologies have made significant strides in recent years. Generative AI, in particular, has changed how we approach various tasks. From content creation to data analysis, AI is becoming an indispensable tool. However, to maximize its potential, we must understand the nuances of its operation. The Importance of AI in Biotech and Pharma In the biotech and pharmaceutical sectors, AI can streamline processes, enhance accuracy, and improve compli

Jeanette Towles
Oct 16, 2025


Certainty as a Strategy: Strengthening Your NDA Filing Strategy Amid Regulatory Whiplash
Learn how Synterex helps biotechs turn regulatory uncertainty into advantage through expert strategy, automation, and AI-enabled efficiency.

Jeanette Towles
Oct 9, 2025


Pharma Scale-Back in the United Kingdom: What It Means for UK Pharmaceutical Regulation
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.

Jeanette Towles
Oct 2, 2025
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