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ISI Boosts European Regulatory Team with 2 New Appointments in Response to Continued Business Growth - Experienced new UK-based regulatory process consultants further enhance ISI’s eCTD, regulatory and outsourcing capabilities as Europe standardises on electronic submissions
ISI Boosts European Regulatory Team with 2 New Appointments in Response to Continued Business Growth

 

NewswireToday - /newswire/ - Eschborn, Germany, 2010/09/08 - Experienced new UK-based regulatory process consultants further enhance ISI’s eCTD, regulatory and outsourcing capabilities as Europe standardises on electronic submissions.

   
 
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The regulatory advisory, solutions and services business of Image Solutions (ISI) in Europe continues to go from strength to strength with the appointment of two new senior team members in the UK.

As electronic drug licence application submissions become the norm across many European markets, demand for ISI’s consultancy, software solutions and outsourcing services continues to experience strong growth. The new appointees, both to the position of regulatory process consultant, are James Hendry and Natalie Herbert.

James, who is fluent in French, joins ISI Europe from Pfizer, where he gained extensive experience with ISI’s Regulatory Solution Suite, document management systems and EU regulatory procedures. He brings to the job eight years’ experience across a variety of regulatory operations roles at Pfizer’s R&D facility in Sandwich, Kent. His most recent position was as senior submission specialist, where he managed a portfolio of five centralised products and six MRP products in the EU, coordinating document supply, advising regulatory strategists on submission formats, and overseeing and helping with submission publishing.

James was also responsible for regulatory operational project-management of several Article 10 Generics MAAs (filed by DCP), a number of first-for-Pfizer paediatrics submissions (PIP Compliance check, Article 29, Article 30), and a number of Swiss submissions. Over the last year, he drove the transition of his products to eCTD, and was heavily involved in designing other submission processes in his capacity as SME for the firm’s Documentum system.

Natalie Herbert, who also brings several years’ experience to the role, joins ISI following an engagement as an independent contractor at GSK Consumer Healthcare. Before that, she worked at Shire Human Genetics Therapies, gaining experience with ISI’s tools as well as with the FirstDoc document management system.

Commenting on the appointments, Adam Sherlock, managing director of ISI Europe, said: “I am delighted to welcome James and Natalie to the ISI Europe fold, where they will be kept busy and challenged by a range of pressing client demands as European requirements for electronic submissions continue to hot up. ISI is experiencing strong business growth as a result of this activity, and these latest appointments will offer further reassurance to our customers that ISI continues to be one step ahead of the needs of the market.”

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 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 organisations 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 recognised charitable organisations.

 
 
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ISI Boosts European Regulatory Team with 2 New Appointments in Response to Continued Business Growth

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