EU CTIS: Europe’s New Clinical Trial Information System
EudraCT has been Europe’s clinical trial database for almost twenty years. But, now it’s the…
Becca Bucci2024 年 5 月 2 日
Why Medical/Regulatory Writing Services Use Style Guides & Lexicons
Learn how style guides and lexicons help medical writers produce clear, consistent, and accurate content…
Jim Gallagher2024 年 3 月 18 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
Leveraging Pharmacokinetic Modeling & Scientific Communications Expertise Advances Sarcoidosis Drug Program
Certara's support, from dose optimization to medical writing, helps pharmaceutical companies advance their research, make…
Danielle Pillsbury2023 年 6 月 1 日
Using Real-World Evidence to Derive an External Control Arm for a Rare Disease Drug Trial
Our client was developing a new anti-viral drug for a rare, life-threatening viral infection that…
Danielle Pillsbury2023 年 4 月 17 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
