As AI adoption accelerates in medical writing, many organizations fall into the trap of automating document-centric workflows without questioning the why behind these outputs. Here lies a regulatory paradox: documents don’t exist for their own sake—they exist to support decisions, satisfy regulatory intent, and ultimately impact patient health. Treating AI integration simply as a means to produce validated templates faster misses its true potential. The strategic fulcrum for

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The FDA’s new announcement, Flexible Requirements for Cell and Gene Therapies to Advance Innovation , signals a notable shift in how regulators are thinking about manufacturing controls during early- and mid-stage development of cell and gene therapies (CGTs). The intent is clear: reduce unnecessary friction, lower barriers to clinical entry, and accelerate innovation for therapies often targeting serious or life-threatening diseases.  At the heart of the guidance are two sta

In clinical documentation software integration, the promise of “plug-and-play AI” has become a siren’s call; just as it is said sailors were lured by the siren’s song only to encounter hidden dangers, clinical teams enticed by the promise of effortless AI integration often discover unforeseen complexities beneath the surface. Vendors often promise effortless automation and streamlined drafting powered by pretrained algorithms that can slot seamlessly into existing workflows—e

The promise of AI-assisted writing in clinical documentation often evokes visions of blazing efficiency and seamless workflows. But beneath the surface lies a stubborn bottleneck that even the most sophisticated algorithms cannot erase: the manual handoffs between authors, reviewers, and disparate systems. This hidden friction point isn’t just a minor inconvenience; it is a systemic tax on time and quality that disrupts the very efficiencies AI aims to unlock and can lead to

Every year, regulatory writing gets a seasonal refresh. New tools, new terminology, new promises that this is the year everything finally gets easier.  And yet.  In 2025, many teams were still relying on the same last-minute heroics, the same “we’ll fix it in review” optimism, and the same unspoken assumption that someone — a tool, a writer, a miracle — would make it all come together at the end.  In 2026, that illusion is finally wearing thin.  What’s changing isn’t the imp

Learn how RAG, CAG, and KAG enhance AI in medical writing by improving accuracy, consistency, and compliance. Discover where each fits in regulatory documentation and how Synterex supports explainable automation through AgileWriter.ai®.

The FDA’s latest innovation signals reveal how regulatory systems are evolving—and what FDA regulatory innovation may increasingly require from industry.

Introduction: What Regulatory Writers Can Learn from UX   In user experience (UX) design, anticipatory design refers to creating solutions before users even realize they need them. Think of it as removing friction by predicting needs and guiding users toward the right action at the right time.  For regulatory writers, the same principle applies: anticipate questions, concerns, and requests for clarification from reviewers before they arise. This forward-thinking mindset imp

Dedham, MA — [ December 15, 2025 ] — Synterex, a WBENC- and DOBE-certified consulting firm specializing in AI-enabled regulatory and clinical writing, announced that AgileWriter.ai®, the flagship module of the company’s AgileSuite™ digital regulatory ecosystem, has joined the Veeva AI Partner Program.  The collaboration will integrate AgileWriter with Veeva RIM, part of the Veeva Development Cloud—the technology foundation that streamlines data and processes across clinical,

The FDA’s move toward single-trial approvals raises the stakes for every pivotal clinical trial. Learn how AI-driven documentation helps teams accelerate and stay compliant.

In today’s high-stakes biopharma environment, speed, compliance, and precision define success. For regulatory and medical-writing teams, optimizing submission-ready content is no longer just operational—it’s strategic. With AI-powered regulatory documentation systems, companies can align earlier with submission requirements, anticipate reviewer expectations, and dramatically reduce rework and costly delays. The result: accelerated approvals, extended runway, and preserved opp