Tag Archives: GlobalSubmit

Transitioning from Paper to eCTD Submissions

A common question that many sponsors ask is, “Can we switch a paper application over to eCTD format?”  The short answer is, “Yes.”  For a more detailed explanation, check out my new guest post over at GlobalSubmit’s blog, The eCTD … Continue reading

Posted in eCTD, FDA, Guest Posts, Regulatory Strategy | Tagged , , , , , , | 2 Comments

Free Educational Webinar – Reasons to Switch to eCTD

UPDATE: The webinar slides are now available for download here (PDF). The eCTD format continues to grow as the standard for regulatory submissions worldwide, and the FDA has made it very clear that it prefers to receive submissions in eCTD … Continue reading

Posted in eCTD, Webinars | Tagged , , , , , , , | Comments Off on Free Educational Webinar – Reasons to Switch to eCTD

Clinical Study Reports to STFs

When working with sponsors who are new to eCTD submissions, one of the most common questions we get is, “What is a Study Tagging File and why do we need one for each clinical study report?”  To explain the importance … Continue reading

Posted in eCTD, FDA, Guest Posts | Tagged , , , , , , , , | Comments Off on Clinical Study Reports to STFs

Free Webinar – FDA Review Process for eCTD Submissions

Navigating eCTD regulations and guidelines is easier said than done. Same goes for assembling and reviewing applications. That’s why GlobalSubmit and Cato Research are offering a free educational webinar on the FDA Review Process on Tuesday, 01 March at 3:00 PM ET. Continue reading

Posted in eCTD, Regulatory Strategy, Webinars | Tagged , , , , , , , , | 2 Comments

Top Reasons to Adopt eCTD Viewing Software

The audience for the eCTD viewer at a drug company ranges from a few users to hundreds or even thousands, depending on the size of the company. Essentially, anyone who writes content, communicates with the FDA, or creates a submission should be using eCTD viewing software. And yet, despite the many advantages and increased global adoption of eCTD submissions, there are still questions and concerns around implementation, in particular among the smaller IND companies. Continue reading

Posted in eCTD, Guest Posts | Tagged , , , , | 2 Comments