Free Educational Webinar: Regulatory and the Cloud Vendor Selection

Software as a service (SaaS, typically pronounced [sæs]), often referred to as “cloud technology” or “on-demand software,” is a software delivery model in which software and its associated data are hosted centrally, typically in the Internet. The combination of ever-more-abundant bandwidth, increasingly powerful processors, and inexpensive storage is broadening the choices for designing, deploying, and using software....

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Regulatory Publishing Software Q&A

During a recent webinar presentation, GlobalSubmit demonstrated how IND & Pre-IND companies use our software 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 communications both internally and with the Agency; improve efficiency and meet important deadlines; reduce risk of technical rejections; and more! We received...

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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...

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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.

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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...

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