Synterex Launches AgileWriter.ai® on Microsoft Azure Marketplace to Accelerate Compliant Submissions for Life Sciences
- Synterex
- 6 days ago
- 2 min read
Azure-hosted AI platform revolutionizes clinical and regulatory writing with automation, traceability, and explainable AI.
Dedham, MA — November 21, 2025 — Synterex, Inc., a global consulting 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-writing platform for life sciences organizations aiming to optimize documentation and submission processes.
AgileWriter is a cutting-edge Azure-hosted digital dossier designed to assist regulatory, clinical, and medical writing teams in automating the authoring, redaction, and formatting of clinical and regulatory documentation. By leveraging advanced technologies such as knowledge graphs, machine learning, and natural language generation (NLG), the platform reduces document creation and formatting time by up to 75%, while ensuring accuracy, compliance, and traceability.
“Making AgileWriter available through the Azure Marketplace simplifies the integration of secure, compliant automation within our clients’ Microsoft ecosystems,” said Jeanette Towles, CEO of Synterex. “This milestone underscores our commitment to responsible AI—helping teams focus on helping patients.”
Built for Compliance, Powered by Azure
AgileWriter seamlessly integrates with Microsoft 365, Azure OpenAI, and Veeva Vault, enabling human-in-the-loop collaboration via prompt-based chat and one-click automation. Each generated document element is fully traceable to its original data source, supported by audit trails and validation logs for transparency and oversight. The platform’s explainable-by-design architecture adheres to industry standards, including Azure Responsible AI principles, 21 CFR Part 11, GxP, and the EU AI Act.
Key Benefits
Accelerate documentation timelines: Reduce time by up to 75% with intelligent automation and validation-ready templates.
Ensure compliance by design: Built-in auditability, explainability, and version control ensure regulatory integrity.
Leverage Azure-native infrastructure: Benefit from robust security, scalability, and global data compliance.
Enable real-time collaboration: Guided workflows and prompt-based tools facilitate seamless collaboration.
About Microsoft Azure Marketplace
The Microsoft Azure Marketplace connects companies seeking innovative, cloud-based solutions with partners who have developed ready-to-use applications and services optimized for Azure. Learn more at https://azuremarketplace.microsoft.com.
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