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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Synchrogenix Writer
Just don't take our word for it


– Associate Director, Medical Writing, Leading biotechnology company


– Editor, Medical Writing, Leading biotechnology company

Trevor Standish
Trevor Standish Associate Director, Product Management


Gabriella Mangino
Gabriella Mangino Product Manager, Synchrogenix

Gabriella Manginoは、患者ナラティブ制作やプロジェクトリーダーとして製薬会社に長年従事してきました。現在Synchrogenix のプロダクトマネージャーである Manginoは、コマーシャルグループやサービスグループと協力し、当社の技術を駆使したオーサリング機能をサポートするソフトウェアの開発と改善に貢献しています。

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