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Why ELSA Is a Step—but Not the Destination—for AI in Regulatory Writing
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

Jeanette Towles
5 days ago


Reducing Redundancy: How Structured Content and AI Reduce Rework in Medical Writing
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.

Katelyn Rivas
Jun 5


AI in Safety Narratives: Streamlining Data Interpretation
Safety narratives serve as a critical component of clinical trial documentation, providing a comprehensive account of a patient’s...
Salimata Ndir
May 19
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