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Runway Extended: How AI-Powered Regulatory Documentation Accelerates Approvals and Mitigates Risk
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

Jeanette Towles
Dec 5


Synterex Launches AgileWriter.ai® on Microsoft Azure Marketplace to Accelerate Compliant Submissions for Life Sciences
Azure-hosted AI platform revolutionizes clinical and regulatory writing with automation, traceability, and explainable AI. Dedham, MA — November 21, 2025 — Synterex, Inc. , a global c onsulting firm specializing in clinical and regulatory operations, agile methodologies, and AI-driven technologies, has announced the availability of its flagship solution, AgileWriter.ai® , on the Microsoft Azure Marketplace. This launch expands access to Synterex’s AI-powered regulatory-writi

Synterex
Nov 21


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

Jeanette Towles
Oct 29


Pharma Scale-Back in the United Kingdom: What It Means for UK Pharmaceutical Regulation
In 2025, several major pharmaceutical companies — including MSD (Merck), AstraZeneca, and Eli Lilly — have scaled back or cancelled planned investments in the UK. Decisions have ranged from pausing vaccine-manufacturing expansions to abandoning research center projects.

Jeanette Towles
Oct 2
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