Precursor chemicals – Sine qua non
Learn about precursor chemicals, and which drug precursors are controlled in the European Union as…
CertaraJune 16, 2026
GlobalSubmit™ PUBLISH: Simplifying global eCTD submissions from one platform
Explore GlobalSubmit PUBLISH for global eCTD publishing and submissions across FDA, EMA, Health Canada, PMDA,…
CertaraMay 18, 2026
The psychedelic executive order and the new U.S. push on psychedelic research and what it actually means for scientists
Learn how the Psychedelic Executive Order is shaping the U.S. push on psychedelic research, accelerating…
CertaraMay 5, 2026
FDA ESG integration: Why now is the time to move beyond manual submissions
Discover how FDA Electronic Submissions Gateway (ESG) integration reduces manual work, improves compliance, and accelerates…
CertaraApril 20, 2026
Regulatory operations best practices for Health Canada submissions
Health Canada submissions now require eCTD/CESG; regulatory operations expert support can streamline the process and…
CertaraAugust 11, 2025
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
Achieve clinical data transparency with the 4 cs of collaboration
In this blog, we look at how you can enhance clinical data transparency and make…
CertaraJanuary 15, 2025
How to respond to health authority questions
Your biotech company has just submitted the marketing application for your first drug product. It’s…
CertaraOctober 25, 2024
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
Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues…
CertaraDecember 12, 2023
