Image Solutions Inc., (ISI), a leader in providing software and service solutions to support the drug development lifecycle, announced today that it will be hosting its inaugural eSolutions Japan: The Global Submission Environment on May 15, 2007.
ISI entered the Japanese market in 2003 when the company forged a strategic relationship with CAC Corporation, a leading provider of Information Technology services. ISI will co-host eSolutions Japan with CAC, providing attendees with an overview of the electronic Common Technical Document (eCTD) regulations, and regulatory agencies’ progress towards accepting submissions in the eCTD format.
ISI and CAC (cac.co.jp) are utilizing the event to review with Japanese companies the emerging submission standards in the United States, Europe and Japan. While Japanese companies have been slow to move to eCTD, in the past year many companies have steadily moved beyond experimental eCTDs and adoption of the standard has been increasing. Up until August 2006, 20 eCTD submissions had been submitted to Japan’s Pharmaceutical and Medical Device Agency. Only four months later, that number had increased to 22.
In addition to the review on regulations, attendees will also have the opportunity to receive a product overview and demonstrations of ISI’s flagship submission products eCTDXPress and ISIPublisher. These products leverage innovative new technology available through the ISI Solutions Platform, an integrating framework for regulatory information management. The event will be held at the Hotel Villa Fontaine Conference Center Shiodome in Tokyo. Those interested can access the registration form at the link provided below.
ISI will also be hosting their 5th Annual US eSolutions 2007 conference October 8-10 2007 in Lake Las Vegas, Henderson, NV. The conference is a powerful composite of information and current solution strategies for Life Science professionals. The focus is electronic submissions, paper and electronic clinical trials and a better understanding of how to successfully navigate through the challenges associated with migrating to systems that fully realize the benefits of today’s regulatory and clinical landscapes.
About Image Solutions, Inc. (ISI)
Founded in 1992, Image Solutions, Inc. (imagesolutions.com) 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 nearly 1,000 electronic submissions and 350 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 organizations.