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
3 takeaways from the FDA oligo guidance you need to know
In June 2022, the FDA published their first oligonucleotide clinical pharmacology specific guidance . This…
Certara2022 年 9 月 23 日
Choosing an eCTD submissions vendor: Your complete checklist
2025 年 9 月 3 日 Selecting the right electronic submission vendor for regulatory submissions to health authorities…
Certara2022 年 1 月 28 日
Why your regulatory writers need eCTD authoring templates
If you’ve heard about eCTD authoring template suites before, but you’re not sure what they…
Certara2021 年 5 月 14 日
