Image Solutions, Inc. | Press Releases

ISI does it again, partnering with Yamanouchi to complete the first eCTD of an NCE

Whippany, NJ (March 14, 2003) - Image Solutions, Inc. (ISI), a leader in delivering superior PDF software products, and outsourcing services to the pharmaceutical industry, has successfully partnered with Yamanouchi Pharmaceutical Co., Ltd., to complete the first fully valid, Step 4 compliant, eCTD of a New Chemical Entity (NCE), for the European Authorities.

Yamanouchi Pharmaceutical Co., Ltd. is a recognized global leader in the Pharmaceutical Industry, dedicated to research and development manufacture and marketing of human prescription drugs and consumer healthcare products in Asia, Europe, and North America. Working with ISI, Yamanouchi achieved corporate firsts by not only submitting the first eCTD to the European Authorities, but also by submitting the dossier (making use of the original CTD granularity) in an eNDA format to the Food and Drug Administration (FDA) in the United States nearly simultaneously. Given the significance of this project, Yamanouchi was not looking for a vendor to merely process their eSubmission documents, but desired a partner to work with them hand-in-hand to ensure timely, successful, submission of these two important projects. ISI proved to be that partner.

Image Solutions, Inc. continues to be a pioneer in the movement toward acceptance and standardization of electronic submissions to worldwide regulatory bodies and the further deployment of the PDF standard. Their landmark work with the first electronic submission to the FDA is included in the Smithsonian Institution's Innovation in Science Collection in Washington, DC. ISI and its experienced staff of trusted eSubmissions experts and proven ISI software tools, including their new ISIToolBox™ Pharma Edition, have once again been a part of a pioneering effort in the pharmaceutical industry.

The two submissions are currently awaiting approval by their respective Regulatory Agencies.

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.