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
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
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
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
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
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
Our experts compiled the tips and best practices you need to know for a successful…
Jim Gallagher2022年11月22日
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
