Creating submission-ready regulatory documents that are consistent in presentation, formatted for eCTD compliance, and aligned with the latest regulatory standards is a complex task. Certara’s eCTD Authoring Templates simplify this process by offering a comprehensive suite of tools designed by regulatory writers for regulatory writers. With features like automatic formatting, advanced macros, and instructional text aligned with current agency guidance, these templates ensure efficiency and compliance from the first draft.
eCTDオーサリングテンプレート
A Springboard to Submission Success
Learn more about eCTD Authoring Templates
By writers for writers
50
time savings on document formatting
280
number of electronic Common Technical Document (eCTD) templates included
5
eCTD templates cover all 5 modules
The foundation of document quality
Certara’s eCTD Authoring Templates allow writers to focus on content, not format. Powerful yet intuitive tools for drafting and review, including easy table creation and automated styling inspection, boost productivity and quality.
Instructional text maintained by regulatory experts ensures compliance with the latest guidance.
Specialized toolbars and macros simplify formatting and table management.
Access to expert advice and technical support throughout the process.
関連製品
なぜサターラが選ばれるのか
Certara combines decades of regulatory expertise with innovative technology to deliver solutions that streamline the drug development process.
30
years of regulatory writing and submission experience
関連情報
全て見るFull Draft Automation with CoAuthor
Take your submission templates to the next level with CoAuthor, an AI-driven authoring tool. CoAuthor combines specialized generative AI capabilities with a suite of smart authoring tools to power efficient and expedited creation of regulatory documents.
Manage your entire submission in one place without compromising on quality, compliance, or timelines.
デモのご相談
Discover how Certara’s eCTD Authoring Templates can transform your regulatory writing process.
Save up to 50% of time on document formatting.
Ensure compliance with the latest regulatory guidance.
Streamline collaboration across writing and regulatory teams.
FAQs
What makes Certara’s eCTD Authoring Templates unique?
These templates are created by regulatory writers for regulatory writers, ensuring compliance and efficiency.
How often are the templates updated?
Templates are updated annually to reflect the latest regulatory guidance.
What support is included with the templates?
Users receive access to technical support, onboarding, and training resources.
