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: GlobalSubmit
药物开发人员常见电子通用技术文件问题解答
Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues to evolve as the pharmaceutical industry adapts to changing regulatory standards and innovative technologies. Because of the inevitable changes, the eCTD presents hurdles to regulatory operations professionals, particularly for those who desire to jump in headfirst and get started using … Continued
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
Synchrogenix eCTD 制作模板套件 - 产品预览
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