FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format Blog FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format 2025 年 3 月 19 日 The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the…Certara2025 年 3 月 19 日
Rolling NDA and BLA Submissions: Accelerate Your Review Timeline Blog 滚动提交 NDA 和 BLA:加快审核进度 We look at the growing regulatory trend of rolling NDA and BLA submissions to help…Certara2025 年 2 月 3 日
GlobalSubmit 4.0 Webinars On-Demand Webinar GlobalSubmit 4.0 网络研讨会 The world of electronic regulatory submissions is about to change with the introduction of eCTD…Danielle Pillsbury2024 年 12 月 3 日
Best Practices for a Successful eCTD Submission Blog 成功递交 eCTD 的最佳做法 Learn common pitfalls that pharmaceutical sponsors encounter during the regulatory eCTD submission procedure and best…Certara2024 年 3 月 5 日
10 Things to Know About eCTD 4.0: Embracing the Future Regulatory Submissions Blog 10 个关于 eCTD 4.0 的须知事项:迎接未来的监管提交 In this blog post, we explore the top 10 things you need to know about…Certara2023 年 10 月 17 日
Maximizing Reusability for Drug Submissions to Different Health Authorities Blog Maximizing Reusability for Drug Submissions to Different Health Authorities Many drug developers have products that they want to submit for marketing approval in several…Certara2023 年 9 月 21 日
The eCTD Submission Process: Tips and Tricks for Drug Development Success White Paper eCTD 提交流程:助力药物开发成功的技巧与诀窍 Our experts compiled the tips and best practices you need to know for a successful…Jim Gallagher2022 年 11 月 22 日
GlobalSubmit WebReview Key Features On-Demand Webinar GlobalSubmit WebReview Key Features Jieun Choe2020 年 6 月 22 日
FDA’s New ANDA Submissions Guidance: Key Points Blog FDA’s New ANDA Submissions Guidance: Key Points The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance…Certara2018 年 9 月 27 日