Best Practices for a Successful eCTD Submission
Learn common pitfalls that pharmaceutical sponsors encounter during the regulatory eCTD submission procedure and best practices for addressing them.
Tag: eCTD
10 个关于 eCTD 4.0 的须知事项：迎接未来的监管提交
As the pharmaceutical industry continues to evolve, so too do the processes for regulatory submissions. One significant development is the introduction of eCTD (Electronic Common Technical Document) 4.0 (read this blog to get a primer on eCTD if you’re not familiar with it). This latest iteration promises to overhaul the way pharmaceutical companies submit their … Continued
Maximizing Reusability for Drug Submissions to Different Health Authorities
Many drug developers have products that they want to submit for marketing approval in several regions like the US (NDA/BLA), Europe (MAA (Marketing Authorization Applications)), Canada (NDS (New Drug Submissions)), and elsewhere. But developing each submission independently can waste a lot of time and money. Fortunately, there are ways to maximize the reusability of your … Continued
The eCTD Submission Process: Tips and Tricks for Drug Development Success
Simplify Your Submissions Review Process With an Anytime, Anywhere eCTD Viewer
Your organization has numerous stakeholders responsible for reviewing the content of your drug submissions which requires approving eCTD submission content quickly, fielding agency questions on the fly, and often entails referencing in-stream as well as historical submissions to do so. The trouble is, without the right eCTD viewing software in place, simple yet critical review … Continued
滚动提交 NDA 和 BLA：加快审阅时间表
Accelerate your FDA review process with a rolling NDA/BLA eCTD submission with Certara’s GlobalSubmit eCTD software and eCTD publishing specialists
