FDA ESG NextGen for Regulatory Submissions Blog 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 On-Demand Webinar 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 On-Demand Webinar 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 Blog 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 Blog 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 Blog 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 Blog 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 White Paper 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 Case Study 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