From molecule to market, Certara is your trusted partner in the drug development journey. Backed by a team of experts and innovative technology, we’re here to guide and support you at every stage. Explore our expertly curated resources, and feel free to reach out with any questions.

AI Enabled Regulatory Writing

• Brochure: From Protocol to Submission: Essential Regulatory Writing Resources
• Schedule a CoAuthor Demo: 针对法规撰写的生命科学专业通用人工智能
• Factsheet: CoAuthor | Factsheet

资源 | Initial Clinical Trial Application:

• Factsheet: 申报审批咨询及相关事务
• 博客：Authoring & Assembling IND & CTA Applications – Insights & Updates
• White Paper: New EU Clinical Trial Regulation

资源 | Mid-Stage Development

• Publication: Clinical Study Protocols: How to Write to Solve Problems Now and Avoid Big Ones in the Future
• 案例研究：使用技术辅助创作功能，改变有关叙事的叙述
• White Paper: Avoid & Fix Common Errors in Regulatory Submissions for Drug Products

资源 | Post Marketing:

• 博客：在汇总安全报告中分类和管理风险
• White Paper: DSUR、RMP 和 PSUR — 统一药物警戒文件
• 网络研讨会点播：RAPS Sponsored Webcast: Author Clinical Study Reports with Data Privacy & Disclosure in Mind
• 博客：专家回答您关于制定 EMA 政策的问题 0070 投稿