Visit Certara in Booth E5 at the DIA Europe 2026 in The Netherlands | March 24-26, 2026
在 Certara，我们携手生命科学领域的创新者，以更快地向患者提供药物。Together we advance modern drug development with biosimulation, regulatory science, and market access solutions. We use software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 66 countries.
CoAuthor™
Regulatory writing technology needs to be smarter, user-friendly, and collaborative—and CoAuthor delivers. It streamlines the process with fast template selection, structured content authoring, and generative AI within Microsoft Word.
通过应用样式指南到超过 280 个符合 eCTD 标准的模板，可节省 50% 的文档格式设置时间。
在您的所有文档中，都可以重复使用您写作中的任何部分，从化合物的名称到关于作用机制的完整段落。
Leverage a biomedically-specialized GPT behind your firewall, for secure, prompt-based text generation
GlobalSubmit eCTD Platform
GlobalSubmit enables teams to manage the regulatory process so they can successfully publish, validate, and review eCTD submissions across a global footprint of regulatory health authorities.
Create submissions that conform to health authorities’ required structure, XML, and validation report, including eCTD 4.0.
Identify and resolve compliance issues before submission, reducing rejection risks with a robust validation engine.
Streamlined Review Process across stakeholders with advanced navigation and annotation features.
