eCTD Archives

Blog

FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format

March 19, 2025 The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the…

CertaraMarch 19, 2025

Blog

Rolling NDA and BLA Submissions: Accelerate Your Review Timeline

We look at the growing regulatory trend of rolling NDA and BLA submissions to help…

CertaraFebruary 3, 2025

On-Demand Webinar

GlobalSubmit 4.0 Webinars

The world of electronic regulatory submissions is about to change with the introduction of eCTD…

Danielle PillsburyDecember 3, 2024

Blog

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

Blog

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

Blog

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

White Paper

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 GallagherNovember 22, 2022

On-Demand Webinar

GlobalSubmit WebReview Key Features

Jieun ChoeJune 22, 2020

Brochure

GlobalSubmit WebReview

Jieun ChoeJune 22, 2020

Blog

FDA’s New ANDA Submissions Guidance: Key Points

The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance…

CertaraSeptember 27, 2018

eCTD

FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format

Rolling NDA and BLA Submissions: Accelerate Your Review Timeline

GlobalSubmit 4.0 Webinars

Best Practices for a Successful eCTD Submission

10 Things to Know About eCTD 4.0: Embracing the Future Regulatory Submissions

Maximizing Reusability for Drug Submissions to Different Health Authorities

The eCTD Submission Process: Tips and Tricks for Drug Development Success

GlobalSubmit WebReview Key Features

GlobalSubmit WebReview

FDA’s New ANDA Submissions Guidance: Key Points

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