RegWriter^™

Our goal is to simplify your life by automating repetitive tasks, allowing your experts to focus on what truly matters.

End-to-End AI-augmented eCTD Module 3 and Regulatory Document Authoring

Designed for the biopharma and medical device industries, RegWriter^TM streamlines the preparation, management, review, and submission of technical documents.

Significantly improve efficiency, reduce costs

Provides instant audit-ready authoring transparency

Single source of truth for all data verification

Let us Partner in your Regulatory Success

Unlock precision and automation with our innovative software solutions. Let's collaborate to build a RegWriter^TM experience that ensures authoring accuracy, efficiency, and compliance every step of the way.

RegWriter™ Implementation Workflow

Evaluate

Collaborate with our experts to assess and define your project requirements

Customize

Tailor RegWriter™ to fit your workflow, terminology, and document types

Training

Optimization with your data and terminology preferences for performance efficiency

Integrate

Integrate RegWriter™ into your existing workflow and required documentation

Implement

Comprehensive training and support for your team and go live with RegWriter™

Chat with us. We can have you experiencing the benefits of RegWriter™ in a matter of weeks.

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Powerful Automation

Harness the power of cutting-edge AI platforms to transform and enhance your regulatory authoring, reducing time-to-submission while ensuring compliance. Expedites and streamlines everyday activities for medical device and biopharma professionals.

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Accuracy and time-saving focused
Centralized and collaborative
Interactive document data transfer