Authoring templates created by writers for writers

Creating submission-ready regulatory documents that are consistent in presentation, appropriate in content, and formatted to be eCTD compliant the first time comes with its unique challenges.

Delays are inevitable when you consider:

  • The amount of training required for the entire submission team to efficiently use Microsoft Word
  • The ever-changing world of updated ICH and regional-specific regulatory authority guidance and forms
  • Imminent changes in appearance and compliance as documents develop

To address these challenges, Certara Synchrogenix paired its technical experts with its regulatory writers and editors to create a comprehensive eCTD Authoring Template Suite, the only template suite created by regulatory writers for regulatory writers.

With toolbar features such as automatic formatting and easy table creation/conversion, our users are spending upwards of around 50% less time on document formatting.

Reduce costly delays

Synchrogenix regulatory teams created the eCTD Authoring Template Suite based on thirty plus years of experience planning, writing, editing, and publishing hundreds of global submissions.

The numerous template features simplify document creation and review and establish a standard approach to document development across different disciplines to ensure efficiencies between writing and regulatory operations teams.

  • Instructional text with current agency guidance maintained by regulatory experts
  • Specialized toolbar containing standardized shortcuts and symbols
    • Advanced macros for one-click formatting and table management
    • Style inspector for ensuring style compliance
    • Document review tools, allowing easy visibility of changes and resolved comments
  • Access to expert advice and technical support at all steps along the way

Without all these efficiencies built into your submission process, costly delays can occur.

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Focus on content, not formatting

Synchrogenix eCTD Authoring Templates users are writing documents right at first draft, spending approximately 50% less time on document formatting, allowing more time to focus on content.

  • Reduce re-work and avoid lengthy delays
  • Access to current guidance at all times
  • Reduce time spent formatting and searching throughout Microsoft Word
  • Eliminate the need to train authors to efficiently use Microsoft Word
  • Feel confident that all documents are consistent per standard styles
  • Streamline the review process
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Write it right first

Because Synchrogenix’s eCTD Authoring Templates were created by its regulatory writers, editors and publishers, you can rest assured knowing that you’re creating submission-ready documents the first time around. This means they are sure to be compliant and consistent, saving your team valuable resources from the start.

Purchase our Templates Suite today to receive:

  • 275+ Common Technical Document (CTD) templates and links to forms and other applicable guidance providing the most current information available
  • Access to expert technical advice
  • Ability to more easily distribute the templates throughout your organization using Windows Installer for one-click installation
  • Installation and user guides, onboarding, and training, including manual practice documents and individualized Q&A session
  • Technical support
  • Annual updates
  • Peace of mind
Read a Blog Post

User Testimonial

Lisa Hove, Senior Regulatory Writer, speaks to her past experience with authoring templates and her thoughts on templates since using the Synchrogenix eCTD Authoring Template Suite.

Tutorial | Table creation and formatting

Say goodbye to inconsistent tables with table creation and formatting made easy with Synchrogenix eCTD Authoring Templates.

Tutorial | Document review tools

Easily see what’s been changed and resolve comments with document review tools included with Synchrogenix eCTD Authoring Templates.

Tutorial | Suite contents

See what contents are included in the Synchrogenix eCTD Authoring Template Suite.
Dawn Guyer Director of Document Quality, Synchrogenix

Dawn has been at Certara for over 13 years. With both regulatory writing and editing experience, she is an experienced submission leader, company trainer, technical editor, project leader, and writer. She leads the Document Quality team, which includes our Technical Editing and QC team.

Justin Savesky Sr. Director, Regulatory Science Technology

Justin has been immersed in the technology field for regulatory science for over eight years.  He leads Synchrogenix technology commercialization efforts, including product strategy and management.

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