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

Features

Packed with features to
boost your productivity

Feature Icon

Regulatory
Guidelines

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

View More
Feature Icon

Graphs
& Tables

Easily add data graphs and tables to your regulatory documents.

View More
Feature Icon

Easy
Collaboration

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

View More
Feature Icon

Audit
Log

Our software automatically builds an audit log of changes.

View More

How it Works

Simplify your writing process

1.
Create A
Project
2.
Add
Contributors
3.
Write
& Review
4.
Merge
& 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
Free Trial Mockup

Recent News

Blog Listing Image

As we celebrate Women's History Month and International Women's Day (March 8th), it's important to recognize the contributions of women in STEM fields.

View MoreCelebrating Canadian Pioneers in STEM for Women's History Month
Blog Listing Image

Collaboration has become a key aspect of modern work, and the digital era has completely transformed the way we collaborate. Gone are the days of endless emails, confusing file versions, and endless meetings.

View MoreThe Changing Look of Collaboration in a Digital Era