Q&A Regulated Product Submissions (RPS)
Oct09

Q&A Regulated Product Submissions (RPS)

Jason Rock, Chief Technical Officer at GlobalSubmit, offered great insight into the topic of Regulated Product Submissions (RPS) or eCTD version 4.0 during a free educational webinar jointly hosted by Cato Research and GlobalSubmit, “Background and Drivers to the eCTD Next Major Version / Regulated Product Submission”, on Thursday, October 4th at 1:00 p.m. EDT.

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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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Move Production of eCTD Submission-Ready Documents Upstream
May18

Move Production of eCTD Submission-Ready Documents Upstream

The role of eCTD-ready source documents and their impact on submission timelines and publishing efficiency is a topic that has been debated for many years. There a lot of naysayers claiming that it’s not possible to compel scientists to produce submission-ready documents, CROs cannot be made to comply with requirements, etc.

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New FDA Study Data Specifications Differentiate Between SDTM, Legacy Formats

In January, FDA issued version 1.5.1 of Study Data Specifications. As discussed in my previous blog entry, a new specification for organizing datasets was defined.   The change has to do with how the files are organized in the file structure in which an eCTD is delivered to indicate whether they were STDM or legacy format. The new specifications for organizing study datasets and their associated files in folders are summarized in the...

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