FDA ESG NextGen for Regulatory Submissions
The FDA ESG NextGen for Regulatory Submissions has replaced the FDA’s WebTrader and simplifies pharmaceutical…
CertaraJune 25, 2025
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.…
CertaraApril 11, 2025
GlobalSubmit 4.0 Webinars
The world of electronic regulatory submissions is about to change with the introduction of eCTD…
CertaraDecember 3, 2024
Best Practices for a Successful eCTD Submission
Learn common pitfalls that pharmaceutical sponsors encounter during the regulatory eCTD submission procedure and best…
CertaraMarch 5, 2024
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…
CertaraDecember 12, 2023
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…
CertaraOctober 17, 2023
Maximizing Reusability for Drug Submissions to Different Health Authorities
Many drug developers have products that they want to submit for marketing approval in several…
CertaraSeptember 21, 2023
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…
CertaraNovember 22, 2022
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…
CertaraJune 3, 2022
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…
CertaraAugust 2, 2021
