Free Webinar: Introduction to eCTD

As you may already know, under the draft PDFUA V bill, electronic submissions will be mandated in Q2 2015. Are you prepared? Navigating eCTD regulations and guidelines is easier said than done. Same goes for assembling and reviewing applications. Your application must be technically sound and structured correctly. Most importantly, it has to be ready for review by the agency upon submission. GlobalSubmit Inc., a leading developer of...

Read More

Free Webinar: Understanding the New FDA Validation Criteria

GlobalSubmit is offering a free educational webinar on Understanding the New FDA Validation Criteria on Thursday, October 20th at 11:00am EDT. During this discussion, we will focus on some of the more important changes to the criteria, when the new validation criteria will go into effect, best practices for ensuring your application is free of technical errors, and more.

Read More

Free Educational Webinar: Reasons to Switch to eCTD

Update: the webinar slides are now available for download here. 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, they still often consider paper submissions as a viable option. That’s why GlobalSubmit and Cato...

Read More

Preparing for the FDA’s eCTD Mandate

Editor’s Note: Our first session is completely full. We have added a second session on December 8th at 11 AM EST. Please follow the link below to register: http://www.eventbrite.com/event/474671756 Don’t have time to keep up-to-date on eCTD regulations and guidance around the world? Wondering when eCTD will become mandatory, (or even accepted), in a given market? Join GlobalSubmit and Cato Research on Thursday, November 5th at 2...

Read More