Chemical data migration best practices – Stage 2: Data curation
How to make existing data - chemical structures along with their additional data - compliant…
Certara2023 年 10 月 26 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
Chemical data migration best practices – Stage 1: Project planning and data assessment
Whitepaper on best business practices, for data migration
Certara2023 年 9 月 4 日
SEND dataset quality control: Best practices & recommendations
In this blog, Senior Product Management Director Peggy Zorn explores best practices & recommendations for…
Certara2023 年 4 月 25 日
New FDA validator rules V1.6 explained
In this blog, we explore what you need to know about the update to the…
Certara2023 年 1 月 12 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…
Certara2022 年 11 月 22 日
New PMDA validation rules 3.0 explained
In this blog, we explore what you need to know about the update to the…
Certara2022 年 3 月 2 日
Industry metrics for CDISC controlled terminology
Sergiy Sirichenko summarizes industry metrics across many studies and sponsors to produce an overall picture…
Certara2021 年 11 月 17 日
