When you align your writing with both your strengths and the world’s needs, you create more than just content - you create impact.  In...

In your role as medical writer, you’ve just been assigned to write a regulatory document. To do your best, you’ll need to...

Discover how AI and structured content management are transforming regulatory submissions—boosting speed, consistency, and compliance in health authority interactions.

The FDA’s recent Evaluation of Labeling Submissions with AI (ELSA) pilot program has generated both curiosity and skepticism in the regulatory community. Early responses from reviewers using ELSA have been mixed, with some finding it helpful for catching inconsistencies or typos, while others found it redundant or disconnected from their workflows. While the effort is laudable, the ELSA pilot highlights deeper limitations in how general-purpose AI tools perform in complex, re

Integrating technology-assisted content reuse into medical writing can reduce stress for writers by preventing unnecessary rework and maintaining consistent document quality and compliance. This ensures timely delivery of important new therapies to the patients who need them. 

Safety narratives serve as a critical component of clinical trial documentation, providing a comprehensive account of a patient’s...