Tag Archive: GlobalSubmit

Sep 07

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 Summit, where I discuss the complete process for converting an IND, NDA, or BLA from …

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Jul 07

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 format. However, when many smaller biotech and pharma companies reach the IND or NDA/BLA stages, …

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Jun 30

Clinical Study Reports to STFs

Module 5 - No STF

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 of Study Tagging Files, we’ve asked Jason Rock, the Chief Technology Officer of GlobalSubmit, to …

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Feb 23

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.

Jan 27

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.

Aug 10

Bookmarks – Collapsed or Expanded?

At Cato Research, part of our standard document preparation work for eCTD submission documents is to save every PDF file with the bookmarks collapsed (i.e. only the top level bookmark is visible when the document is opened).  We’re often asked if there is a specific reason that we do this, since the FDA eCTD guidances …

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Aug 04

GlobalSubmit Suite 2010 Beta Test

GlobalSubmit is hard at work on the next version of their software suite.  In addition to several improvements to both REVIEW™ and VALIDATE™, the next update will also include PUBLISH™, their long anticipated eCTD and RPS publishing tool.  As I’ve previously mentioned, I joined the GlobalSubmit team at DIA 2010 and was given a demonstration of …

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Jun 14

DIA’s 46th Annual Meeting

The DIA Annual Meeting is one of the premier events for professionals involved in the discovery, development, and lifecycle management of pharmaceuticals, medical devices, and related products. With 25 content-area tracks, 330 sessions and 20 tutorials, presentations are geared to attendees at all disciplines, works settings, and experience levels. This year’s meeting is being held …

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Jun 14

DIA's 46th Annual Meeting

The DIA Annual Meeting is one of the premier events for professionals involved in the discovery, development, and lifecycle management of pharmaceuticals, medical devices, and related products. With 25 content-area tracks, 330 sessions and 20 tutorials, presentations are geared to attendees at all disciplines, works settings, and experience levels. This year’s meeting is being held …

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Apr 19

Advice for Sponsors New to eCTD

Recently, GlobalSubmit‘s Kathie Clark took an opportunity to sit down with Cato‘s Director of Regulatory Operations, Evan Richardson, and talk about Cato’s experience with sponsors who are new to eCTD submissions.  Kathie published her interview with Evan this morning in a blog post titled, “Advice from Evan Richardson, Cato Director of Reg Ops, for Sponsors …

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