top of page
Profile
Join date: May 23, 2025
Posts (53)
Nov 3, 2025 ∙ 2 min
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.
9
0
Nov 3, 2025 ∙ 2 min
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.
4
0
Oct 29, 2025 ∙ 3 min
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
11
0
Jeanette Towles
Writer
CEO
More actions
bottom of page