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

By partnering with us, you'll gain access to industry-leading expertise and innovative software solutions that adapt to your unique challenges. Let's collaborate to build a customized RegWriter^TM experience that ensures accuracy, efficiency, and compliance every step of the way.

RegWriter™ Implementation Workflow

1. Evaluate and Scope

Collaborate with our experts to assess and define your project requirements

2. Customization

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

3. Train RegWriter™

Optimize the tool with your data and terminology preferences for performance efficiency

4. Set Up and Integrate

Implement RegWriter™ into your existing systems and set up required documents

5. Train and Launch

Comprehensive training 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

Next-generation tools to support regulatory strategy, submissions, clinical research, and expedite everyday activities for medical device and biopharma professionals.

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