Image Solutions, Inc. | Press Releases

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

Whippany, NJ (August 18, 2005) – Image Solutions, Inc., (ISI) a global technology company and leader in providing software solutions and services for electronic regulatory submissions and clinical trials management, announced today that it has filed a milestone 100 th eCTD (electronic Common Technical Document) submission on behalf of their pharmaceutical clients . ISI’s clients remain the foremost Life Science organizations representing 47 of the top 50 Pharmaceutical and Biotech organizations worldwide. The eCTD is a globally accepted electronic submission structure emerging as the standard for the United States, the European Union, and Japan for new drug submissions.

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 firms to deliver electronic submissions to the industry and since has delivered thousands of electronic and eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organizations as well as the top companies in other regulated industries.

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.

Image Solutions, Inc., ISIToolBox, eCTDXPress, ISIPublisher and ISIRegTracker are trademarks or registered trademarks of Image Solutions, Inc. which may be registered in the United States and internationally. Other brand names may be trademarks or registered trademarks of others.