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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.

自動フォーマットや簡単な表作成/変換などのツールバー機能により、文書フォーマットにかかる時間が約 50% 減少しています。

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.

数多くのテンプレート機能により、文書作成とレビューを簡略化します。また、ライティングチームと規制業務チームとの間で業務が効率的に進むよう、さまざまな分野にわたる文書策定の標準的なアプローチを確立します。

  • 規制エキスパートに管理された、規制当局が発出する最新のガイダンスが記載された教本
  • 標準化されたショートカットおよびシンボルを含む、専門分野別のツールバー
    • 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
  • 進行中のすべての段階で、アクセスできる専的な助言と技術的なサポート

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

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Reduce costly delays
Focus on content, not formatting

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
  • テクニカルサポート
  • Annual updates
  • Peace of mind
Read a Blog Post
Write it right first
YouTube video

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.

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Tutorial | Table creation and formatting

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

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YouTube video
YouTube video

Tutorial | Document review tools

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

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Tutorial | Suite contents

See what contents are included in the Synchrogenix eCTD Authoring Template Suite.

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headshot dawn Guyer
Dawn Guyer Director of Document Quality, Synchrogenix

サターラにて13年にわたってメディカルライターとして活躍しています。レギュラトリーライティングと文書校正の両方の業務を経験し、経験豊富なチームリーダー、社内トレーナー、テクニカルエディター、プロジェクトリーダー、さらにライターとしての顔を持っています。現在、当社のTechincal EditingおよびQCチームも含むDocument Qualityチームを統括しています。

Justin Savesky
Justin Savesky Sr. Director, Regulatory Science Technology

Justinはは8年以上にわたってレギュラトリーサイエンスのテクノロジー分野に従事しています。製品戦略や管理、規制関連のテクノロジー製品化プロジェクトを統括しています。

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