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 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.
借助于工具栏的功能，如自动格式化和简单的表格创建/转换，我们的用户在文档格式化上所花费的时间减少了大约 50% 以上。
Reduce costly delays
Certara regulatory teams created the eCTD Authoring Template Suite based on thirty plus years of experience planning, writing, editing, and publishing hundreds of global submissions.
大量的模板功能简化了文档的创建和审核，并建立了跨不同学科进行文档开发的标准方法，从而确保编写和监管操作团队之间的效率。
- 由监管专家维护的现行机构指南的指导性文本
- 包含标准化快捷方式和符号的专用工具栏
- 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
- 在整个过程中获得专家建议和技术支持
Without all these efficiencies built into your submission process, costly delays can occur.
Focus on content, not formatting
Certara 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
Write it right first
Because Certara’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
- 技术支持
- Annual updates
- Peace of mind
User Testimonial
Lisa Hove, Senior Regulatory Writer, speaks to her past experience with authoring templates and her thoughts on templates since using the Certara eCTD Authoring Template Suite.
Tutorial | Table creation and formatting
Say goodbye to inconsistent tables with table creation and formatting made easy with Certara eCTD Authoring Templates.
Tutorial | Document review tools
Easily see what’s been changed and resolve comments with document review tools included with Certara eCTD Authoring Templates.
Tutorial | Suite contents
See what contents are included in the Certara eCTD Authoring Template Suite.
Dawn 已在 Certara 任职超过 13 年。她拥有监管写作和编辑经验，是一位经验丰富的提交负责人、公司培训师、技术编辑、项目负责人和作家。她带领着文件质量团队，其中包括我们的技术编辑和质量控制团队。
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.
Dawn 已在 Certara 任职超过 13 年。她拥有监管写作和编辑经验，是一位经验丰富的提交负责人、公司培训师、技术编辑、项目负责人和作家。她带领着文件质量团队，其中包括我们的技术编辑和质量控制团队。
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.
