Regulatory Operations Best Practices for Health Canada Submissions
Health Canada submissions now require eCTD/CESG; regulatory operations expert support can streamline the process and…
Certara2025 年 8 月 11 日
FDA ESG NextGen for Regulatory Submissions
The FDA ESG NextGen for Regulatory Submissions has replaced the FDA’s WebTrader and simplifies pharmaceutical…
Certara2025 年 6 月 25 日
eCTD 4.0: When & Where it will be Implemented Next
Associate Director, Regulatory Operations Over 20 years of experience in eCTD submissions and FDA interactions.…
Certara2025 年 4 月 11 日
GlobalSubmit eCTD 4.0 Webinars
The world of electronic regulatory submissions is about to change with the introduction of eCTD…
Certara2024 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
Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions
Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues…
Certara2023 年 12 月 12 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
