Kate’s experience and leadership will be instrumental in driving the success of the ISI regulatory services practice
Blended Regulatory Operations and Consulting Group is formed by ISI in response to European regulatory services growth
Eschborn, Germany – January 21st, 2009 – Image Solutions Inc. (ISI), a leading provider of software and services for the life sciences industry, today named Kate Wilber to the position of Director of Regulatory Services, Europe, effective immediately. Kate has been promoted from her role in ISI’s European regulatory consulting practice, a position she assumed in July 2008.
The ISI European Regulatory Services group combines both the regulatory operations and regulatory consulting lines of business, enabling ISI to place strategy and consulting front and centre in its market approach supported with tactical operational offerings. In her new role, Kate will continue the development of the ISI portfolio of services and expand the capabilities that ISI can bring to the market to help European pharmaceutical organisations overcome the complex challenges presented by constantly evolving standards around regulatory submissions.
“This is a much deserved promotion for Kate who has made a significant impact on the regulatory consulting practice since she joined us last year,” said Adam Sherlock, Managing Director, ISI Europe. “Kate’s experience and leadership will be instrumental in driving the success of the ISI regulatory services practice in what is an increasingly complex European pharmaceutical landscape that presents many new services opportunities for ISI.”
Kate, who joined ISI’s regulatory consulting practice in July last year, is a US national based in England. Kate formerly served as Senior Global Regulatory Operations Manager at Shire Pharmaceuticals. During that tenure, Kate served as business lead on a cross-functional electronic Common Technical Document (eCTD) implementation team.
In this role, Kate collaborated with external consultants to define global eCTD metadata standards; addressed training needs throughout regulatory affairs as well as across R&D; and managed multiple major submission publishing teams for both US and EU applications. The role also included the implementation of ISI’s eCTDXPress and ISIPublisher business solutions. Prior to joining Shire, Kate worked at another electronic submission vendor for three years, most recently as a Product Manager for the publishing solutions business. She graduated with a Bachelor of Science degree in Mathematics from Dickinson College in Carlisle, Pennsylvania.
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 organizations. 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.
Carina Birt, Sarum
PR for ISI
+44 1722 411150
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