Simplify your writing process with the Otium Regulatory DocWriter™!

The first document writer built specifically for regulatory documents. We streamline the most time-consuming stages of setting up Investigator Brochures (IBs), Clinical Study Reports (CSRs), Clinical Study Protocols (CSPs), Informed Consent, Trial Disclosure Forms, and similar documents.

Otium software


Packed with features to
boost your productivity

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Start with templates based on ICH, GCP, and TransCelerate guidelines.

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& Tables

Easily add data graphs and tables to your regulatory documents.

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Review your documents with writers, reviewers, and study experts.

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Our software automatically builds an audit log of changes.

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How it Works

Simplify your writing process

Create A
& Review
& Publish

Powerful and easy to use regulatory writing platform

Regulatory DocWriter™ features the necessary guidelines to ensure writers are within compliance when creating, reviewing, and submitting their documents to regulatory bodies. The platform works with you to provide the structure to create documents based on the regulatory templates, while providing you tools to ensure the content meets your specific needs.

Cost Effective

No up-front costs, and a simple monthly subscription that pays off with increased productivity, collaboration, and compliance.

Regulatory DocWriter is designed for

Trusted by Regulatory Writers

Testimonial Quote

I love Otium Regulatory DocWriter™ because it saves me hours of time when setting up a new regulatory document, and incorporating feedback from reviewers is so easy!

Testimonial Client

Todd Elton

Medical Writer
Testimonial Rating
Work Content Layout

Finally a writing tool that is designed for medical writing documents. I love the DocWriter™ system!

Testimonial Client

Iva Angel

Medical Writer
Testimonial Rating

Get started with a 30-day free trial

Start creating regulatory documents for your organization with Otium's 30-day free trial. No commitment.

Get Started
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Recent News

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October 13, 2022

Medical writing software is must-have; however, until now medical writers have had few good options. In particular, there has not been any software designed to efficiently cut down on the time required to produce regulatory documents.

View MoreMedical Writing Software

October 13, 2022

Otium will be attending the CTO 2022 Clinical Trials Conference.We would love to see you November 10 & 11, 2022 in Toronto! Please drop by our booth to see a demo of our new Regulatory DocWriter™ software. We hope to see you there!

View MoreOtium will be at the CTO 2022 Conference