eCTD Review

PDF Update

Last month, I attended a conference focused on pharmaceutical regulatory writing and submissions in Baltimore, MD. During the two-day conference, a number of discussions and questions pertained to PDF files. As many of you may have similar questions or experiences, I wanted to share the questions and answers to provide some greater insight into PDFs in relation to electronic submissions…. Read more →

How the FDA uses REVIEW and VALIDATE

Each center, division, and reviewer uses GlobalSubmit REVIEW™ and VALIDATE™ differently. Besides loading and validating submissions, VALIDATE is used to reject submissions for technical reasons. If VALIDATE reports a high error, your submission could be rejected. This rejection could take up to five days to be reported. When an original or supplement is rejected, your PDUFA time clock will not… Read more →

Webinar Recap: IND & Pre-IND Company Demo

GlobalSubmit kicked off its second quarter Lunchtime Webinar Series with a presentation for IND & Pre-IND Companies. During this presentation, GlobalSubmit demonstrated how IND & Pre-IND companies use our tools to see the same views as the FDA; build their application as the FDA sees it; cut days off the time it takes to quality check bookmarks and hyperlinks; improve… Read more →

Webinar Recap: Intro to eCTD

GlobalSubmit recently held an educational webinar entitled Intro to eCTD. Under the draft PDFUA V bill, electronic submissions will be mandated in Q2 2015. Given this recent news, GlobalSubmit offered this free webinar to provide a comprehensive overview of the eCTD, including everything from basics and terminology to rules and regional standards to submission output and solutions, and more. If… Read more →

Free Webinar: Intro 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… Read more →