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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


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


Understanding Context Engineering in AI: A Game-Changer for Clinical Trial Professionals
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

Jeanette Towles
Oct 16


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


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


Are Your AI Tools Introducing New Compliance Risks in the EU?
Join regulatory and legal experts from Synterex, JURISolutions Legal, Jaguar Health, and AVS Life Science in this Sept. 24, 2025 webinar on the GDPR and EU AI Act.

Synterex
Sep 16
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