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AI-Powered Regulatory Writing.
In Minutes, Not Months.
Craft regulatory documents that are clear, concise, and consistent—every single time. Powered by domain-trained AI built specifically for medical writers.
Why ProWriter?
Because regulatory writing deserves better tools.
Most medical writers juggle dense data, shifting templates, and rigid style guides—with outdated tools that weren’t built for the job.
ProWriter changes that.
It’s not just another AI assistant. It’s trained on real regulatory standards, understands the nuances of clinical documentation, and works with you—not instead of you.
✅ Purpose-built for regulatory writers — not general-purpose GPTs
✅ Trained on ICH, EMA, and FDA guidance
✅ Designed to reduce manual edits and review cycles
✅ Compliant, traceable, and transparent
ProWriter lets you focus on writing with impact, not wrestling with formatting, phrasing, or version control.
Clarity by Design
AI-driven plain-language suggestions turn complex clinical findings into reader-friendly narratives—without compromising precision.
Real-time collaboration
Work smarter, not harder, with built-in collaboration features. Sync your efforts with your team, and let ProWriter handle the rest.
Concise, Yet Complete
Dynamic length controls keep your writing laser-focused on endpoints while ensuring no critical details are left out.
Consistency Everywhere
Terminology, units, and writing style are harmonized across the entire document—updated instantly with a single click.
How It Works
Import Study & Template
Upload your clinical study report (CSR), CTD modules, or use a built-in template. ProWriter auto-maps your data to the right structure.
AI Draft & Review
Generate first drafts instantly. Refine with AI chat trained on ICH, EMA, and FDA guidelines—inline and in-context.
Export & Track
Export to Word, PDF, or integrate directly with your document management system. Includes full audit trail and versioning.
We build with your security in mind.
Rest assured, ProWriter uses end-to-end encryption to protect your data, providing you with the peace of mind that comes from knowing your information is secure and handled with your best interests in mind.
GDPR | CCPA compliant | HIPAA compliant
Ready to transform your regulatory writing?
