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
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…
CertaraSeptember 23, 2022
Choosing an eCTD submissions vendor: Your complete checklist
September 3, 2025 Selecting the right electronic submission vendor for regulatory submissions to health authorities…
CertaraJanuary 28, 2022
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…
CertaraMay 14, 2021
