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Image Solutions, Inc.’s Completes 100th eCTD Submission

As of July 15 th, ISI has submitted 86 eCTDs to CDER at the FDA and 14 eCTDs to the EMEA, all without a “Refusal To File” (RTF) which typically results when there are problems with missing documents or unresolved hyperlinks in a submission.

This milestone accomplishment demonstrates ISI’s continuing leadership position in this rapidly evolving area of regulatory document standards. Since 1992, ISI has pioneered innovative electronic submission and document management tools, earning them the reputation as the leader in delivering exacting quality while improving their client’s speed-to-market timeliness, and obtaining regulatory approval for new medicines.

About Image Solutions, Inc.

Founded in 1992, Image Solutions, Inc (ISI) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firm to deliver electronic submissions to the industry and since has delivered thousands of submissions. The company has a 49 percent market share among Top 50 global pharmaceutical for its flagship submission product, eCTDXPress, and 4 of the top 10 pharma now have ISIPublisher.

ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to over 20 recognized charitable organisations. For more information, visit the company website at:
www.imagesolutions.com.

 
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