Jason Rock

Chief Technical Officer, Co-Founder

Jason Rock is a pioneer in the field of electronic submissions. Mr. Rock has an extensive background working with global life sciences companies and regulatory agencies to promote eCTD adoption through the development of advanced applications. The commercial software Mr. Rock originally developed, and continues to improve, in his role as Chief Technical Officer for GlobalSubmit, is used exclusively by the U.S. Food & Drug Administration to review and validate all eCTD submissions the FDA receives.

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Mr. Rock’s innovative application of the Agile development philosophy to GlobalSubmit’s submission publishing process has proven revolutionary for keeping submission timelines on track and documents in compliance. Using Mr. Rock’s process, GlobalSubmit has completed 75% of all submissions ahead of the projects’ targeted submission date.

Mr. Rock has served as a delegate to the International Conference on Harmonization (ICH) and Chair to the HL7 Regulated Products Submissions (RPS) group, advocating for decisions beneficial to the health care industry as a whole. Mr. Rock draws on his experience and insight to educate end users and various industry stakeholders on the finer points of electronic submissions. He regularly presents at industry meetings, publishes articles, and hosts educational webinars.

Mr. Rock graduated from Rutgers University with a bachelor’s degree in Biological Sciences.

Articles and Presentations

Expectations for the Implementation of eCTD v4, eCTD Summit, September 27, 2016

FDA’s New Module 1 is a Bridge to eCTD 4, eCTD Summit, September 13, 2016

Document Reuse, Lifecycle and Metadata Overhauled in eCTD v4.0, eCTD Summit, July 7, 2016

Dissecting eCTD 4, eCTD Summit, June 23, 2016

How Unwritten Agency Rules Affect eCTD System Migration, eCTD Summit, February 25, 2016

How We Moved to Agile for Regulatory Submissions and Why It Works, eCTD Summit, September 5, 2015

Module 1 Education Series—Using the New FDA Metadata, Webinar, June 9, 2015

The Undocumented STF Lifecycle Management, eCTD Summit, November 12, 2014

Compound Documents Left Out of RPS Standard, eCTD Summit, June 6, 2014

The Latest on FDA Tobacco Submissions, eCTD Summit, August 8, 2013