
Conference: DIA 欧洲 2025
日期 March 18-20, 2025
地点 Basel, Switzerland
展位: F2
敬请莅临瑞士巴塞尔 DIA 欧洲 2025 展 F2 展位的 Certara 展台 | March 18-20, 2025
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 275 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 any or all of 9 health authorities’ required structure, XML, and validation report.
- Review eCTD submissions across stakeholders prior to submitting
预约演示
资源
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Schedule a CoAuthor Demo: 针对法规撰写的生命科学专业通用人工智能
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Factsheet: CoAuthor | Factsheet
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Factsheet: 申报审批咨询及相关事务
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White Paper: New EU Clinical Trial Regulation
- Factsheet: Certara 战略早期开发解决方案
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案例研究:使用技术辅助创作功能,改变有关叙事的叙述
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Blog: 在汇总安全报告中分类和管理风险
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White Paper: DSUR、RMP 和 PSUR — 统一药物警戒文件