Streamline your drug development program’s regulatory and medical writing

Getting regulatory approval for an investigational drug requires a massive number of regulatory documents to be written for the submission package. This process can be slow and inconsistent between writers.

Revolutionize the work of your writing teams with Synchrogenix™ Writer. Certara’s software is a purpose-built writing tool designed by writers for writers that encompasses organization, collaboration, and automation to generate your regulatory documents. Unlike traditional word processing software to write reports, this cloud-hosted and validated regulatory software allows you to measurably streamline your processes.

Free your regulatory and medical writers from mundane tasks

Synchrogenix Writer is a turnkey software that improves team collaboration. By utilizing clinical trial data, experts focus on messaging while relying on the software to do the laborious task of putting all the pieces together. As a result, Synchrogenix Writer reduces content review meetings and increases productivity.

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Ensuring consistency and quality

In regulatory documentation workflows, consistency and quality of content are top of mind. By utilizing standard clinical trial data, outcomes are directly populated into a writer’s template. This translates into repeatable content, with identical structure, and unmatched consistency.

Drive efficiency to a whole new level

Expect each writer to achieve more with Synchrogenix Writer. Built in capabilities such as real time previewing and auto-generation enables natural language content that meets the stringent requirements of the regulatory space.

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Just don't take our word for it

“You would not be able to tell forty different writers were authoring these. It looked as though one person was writing them! The writers wrote a streamlined and visually-cohesive and consistent story that made reviewing the large set by only a few reviewers extremely efficient. This software is extremely valuable.”

– Associate Director, Medical Writing, Leading biotechnology company

“The fact we could produce the first drafts so quickly was a key benefit for our timeline. And the fact that the quality control review was built in was an additional factor that contributed significantly to meeting our timeline goal.”

– Editor, Medical Writing, Leading biotechnology company

Our Experts:
Trevor Standish
Trevor Standish Associate Director, Product Management

Trevor brings vast experience in developing product strategy, roadmaps, and requirements with cross-functional teams to launch successful software products. He has spent the last decade creating and managing disruptive technologies in finance, marketing, and pharma. His focus on collaboration between customer and company aligns incentives delivering successful results.

Gabriella Mangino
Gabriella Mangino Product Manager, Synchrogenix

Gabriella Mangino has years of patient narrative production and project lead experience in the pharmaceutical industry. As a Product Manager at Synchrogenix, Ms. Mangino works with the commercial and services groups to help develop and improve the software that supports our technology-enabled authoring capabilities.


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