Synterex Blog

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

In the evolving landscape of regulatory writing, it has become clear that creating clear and compliant documents is no longer enough. Building off the principles of lean authoring, regulatory writers must now consider holistically the experience of those who will review the documents.

What is a Biosimilar? In the scientific realm, biosimilars, akin to their reference products, are biologic medications. Approval for biosimilars hinges on demonstrating no clinically significant differences in safety and efficacy compared to the reference products.

In recent years, lean authoring principles have emerged as a cornerstone for efficient and effective communication. These principles, which emphasize planning, avoiding redundancy, and using precise language, are especially relevant in technical and professional writing.

In the rapidly evolving landscape of artificial intelligence (AI), the 11 × 11 tipping point has emerged as a critical concept. This tipping point refers to the moment when AI technologies reach an optimal level of efficiency and effectiveness.

Prepare for a successful Quality Control review! Download this poster, presented by Synterex at the 2023 American Medical Writers Association (AMWA) conference, or scroll down for a text-only version.