ISI Receives ISO 27001:2005 Certification in Tianjin, China

ISI Receives ISO 27001:2005 Certifications in Tianjin, China

ISO recognizes ISI’s Tianjin offices for excellence in data securityCertification marks important benchmark in plans for global certification offeringWhippany, NJ (January 7, 2008)-Image Solutions, Inc. (ISI), a leading provider of software and services for the life sciences industry, today announced that its Tianjin, China office was granted ISO 27001:2005 certification by the International Organization for Standardization (ISO). ISI received the accreditation for meeting exacting Information Security Management Systems standards in the areas of Regulatory Operations and Submission Processes for life sciences organizations.

As life sciences firms look to reign in research and development costs through outsourcing partnerships, while maintaining the confidence that data is secure and authenticated, certifications from ISO have become more important than ever. ISI’s Tianjin office offers significant cost savings to clients, making it an attractive part of the company’s outsourcing offering.  In addition to the cost savings, ISI offers increased capacity to handle a larger volume of projects in a short timeframe by operating global offices in different time zones.
 
“Downward cost pressure-particularly in R&D-has pharmaceutical companies of all sizes looking for the combination of China pricing with the reliability of a proven domestic partner,” said Jinsoo Kim, president and chief executive officer of ISI. “More than ever, firms are asking ISI to manage entire regulatory submissions because it removes the steep learning curve of the global regulatory landscape.”
 
The certification, along with ISI’s plans to pursue certification for its U.S. and European offices, demonstrate ISI’s ongoing commitment to establishing a global offering.  The Tianjin audit was conducted by Det Norske Veritas, a leading global provider of risk management consulting and certification solutions.
 
The ISO 27001:2005 certification will provide ISI with numerous benefits, including access to new markets that require certification and new opportunities in existing markets that require a company to have the ISO 27001:2005 certification.
ISI now has more than half of its 400 global employees involved in regulatory operations in offices around the world, namely in the United States, Germany and China.  The Tianjin, China, office focuses mainly on document processing, and is expected to help ISI double its processing of electronic Common Technical Document (eCTD), the preferred format for electronic regulatory submissions, over the next year.

Most of ISI eCTD’s work-some 90 percent-entails submissions to the United States FDA, but with ongoing global efforts to harmonize eCTD regulatory standards, ISI is helping clients prepare submissions in an expanding list of countries. In the European Union, all national competent authorities must be capable of receiving eCTD-only submissions for Mutual Recognition, Decentralized, and Nationally-registered products by the beginning of 2010, per a Heads of Medicines Agencies agreement.  For products registered through the Centralized Procedure, the European Medicines Agency (EMEA) has set the following timelines: as of July 1, 2009, EMEA will strongly recommend eCTD-format electronic-only submissions; as of 1 January 2010, EMEA will mandate eCTD format submissions.

In addition to its pioneering regulatory software, ISI provides medical writing, regulatory consulting, biometrics, implementation/IT services, electronic submission outsourcing and education services for life sciences and biotechnology companies around the world.
 
About Image Solutions

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 53 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 organizations. For more information, visit the company website at www.imagesolutions.com