eCTD 4.0: When & Where it will be Implemented Next
2025 年 5 月 14 日 - 10am ET
Danielle Pillsbury2025 年 4 月 11 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…
Rob Connelly2024 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…
Rob Connelly2023 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…
Danielle Pillsbury2023 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…
Danielle Pillsbury2023 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
Providing Around-the-Clock Regulatory Support While Enhancing Team Chemistry
Advaxis Inc. is devoted to the discovery, development, and commercialization of immunotherapies based on a…
Becca Bucci2022 年 6 月 3 日
Takeover of lifecycle maintenance of investigational new drug applications
A Tier 3 Sponsor with active clinical investigations and multiple active, existing Investigational New Drug Applications (INDs) was unhappy with their current vendor’s support. The Sponsor selected Certara as its new vendor for…
Jim Gallagher2021 年 8 月 2 日
Strategic Planning and technology to support a rolling BLA submission under tight timelines
A Tier 3 Sponsor called upon Certara to support its rolling BLA submission, the second…
Jim Gallagher2021 年 7 月 19 日
