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ISI Receives New ISO 9001:2000 Certifications in California and New Jersey

  • ISO 9001:2000 certification recognizes ISI’s CA and NJ offices for regulatory operations and submission processes excellence
  • Certifications build on ISI’s 2007 ISO 9001:2000 certification in China
  • ISI plans to seek certification for European offices to create global certification offering

Whippany, NJ (June 9, 2008) – Image Solutions Inc. (ISI), a leader in providing software and services to streamline the drug development and regulatory approval process, today announced that its San Bruno, CA and Whippany, NJ offices were granted ISO 9001:2000 certification by the International Organization for Standardization (ISO) for meeting exacting Quality Management Systems standards in the areas of Regulatory Operations and Submission Processes for life sciences organizations. The audit was conducted by the British Standards Institute, a leading global provider of management systems assessment and certification solutions.

In addition to its certifications in the U.S., ISI was granted ISO 9001:2000 certification for its Tianjin, China office in late 2007. These certifications, along with ISI’s plans to pursue certification for its European offices, demonstrate ISI’s ongoing commitment to establishing a global offering.

“ISI is committed to providing high-quality solutions on a global level,” said Jinsoo Kim, president and chief executive officer of ISI. “Receiving the ISO 9001:2000 certifications for our California and New Jersey offices affirms ISI’s position as a leader and sets the stage for a truly global solution.”

ISI has a history of commitment to quality and has long followed the guidelines set by an internal quality policy that details meeting customer expectations and improving internal processes year after year. These guiding principals not only made the ISO 9001:2000 certification easier, but they also make implementing the ISO framework seamless.

The ISO 9001:2000 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 9001:2000 certification.

A Flexible Solution for Firms of All Sizes
In addition to its pioneering regulatory software, ISI provides medical writing, regulatory consulting, implementation/IT services, electronic submission outsourcing and education services for life sciences and biotechnology companies around the world.

Tags: Image Solutions, Inc.; ISO 9001:2000; Regulatory Operations; Submission Processes; electronic submissions; drug development; drug development technology; pharmaceutical industry; biotechnology

Suggested Links: ISI Website

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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