San Francisco Office Doubles Staff; San Diego Office to Offer Regulatory
WHIPPANY, N.J., Aug. 15 /PRNewswire/ -- Image Solutions, Inc. (ISI), a leader in providing software and services to streamline the drug development lifecycle, today announced the expansion of its San Francisco office and opening of a new facility in San Diego. The announcements illustrate the company's newly elevated focus on emerging West Coast biotechnology, pharmaceutical and Life Sciences companies, and solidify its position as a local strategic partner for companies that require support for regulatory operations and go-to-market strategies designed to expedite the approval of new medicines.
"California is a hotbed for innovation in the Life Sciences industry because of the state government's support and the community's focus on fostering scientific breakthroughs," said Jinsoo Kim, founder, president and chief executive officer. "We are well positioned to serve this market and look forward to expanding our existing customer base throughout the state."
The biotechnology industry in California is supported by state legislation and a local infrastructure that provides support for its growth, including local academic institutions, venture capital pools for emerging companies, incubators, and large pharmaceutical companies. ISI's San Francisco office has benefited from these conditions for three years, triggering the company to hypothesize that other parts of the state hold promise as well. In San Diego, there are currently 500 companies employing more than 6,600 employees in emerging technology industries. The San Diego Association of Governments estimates that these companies have an annual economic impact of $8.5 billion.
A June 2007 focus group in San Diego supported ISI's contention that there was a strong market demand for flexibly packaged offerings. One of the chief findings was that emerging Life Sciences firms are fundamentally interested in packages that provide document management and electronic regulatory submission tools that can grow with their needs and future business plans, and outsourcing support that can help them meet major submission milestones. Given this feedback - as well as additional research on the typical stage and phase of products these companies have in development that dovetail perfectly with ISI's core offerings - the California investments made perfect sense.
"Through our research, we've learned that many emerging companies may not have the regulatory or IT support to prepare for some of the new regulations," said Sue Simpson, managing director of West Coast operations for ISI. "These companies' regulatory support staff generally is limited to one person who may need help understanding the challenges inherent to drug development, compliance and validation. ISI is helping to fill that knowledge gap by providing software and regulatory guidance to help steer these companies through the process."
To address the need for compliance support, ISI has announced two additions to their California regulatory staff: Annette Nilsen, senior regulatory consultant; and Sunshine Bruce, regulatory consultant. Nilsen possesses nine years experience in publishing paper and electronic new drug submissions as well as seven years project management experience with top pharmaceutical companies including Elan Pharmaceuticals and Pfizer, Inc. Nilsen will be working from the San Diego office. Bruce previously was employed by Allergan in the regulatory affairs group and possesses a wide range of business and technology skills. Bruce will be working from the San Francisco office.
ISI's West Coast services include regulatory operations and outsourcing capabilities and training, as well as regulatory consulting and staff augmentation. The office also supports software implementation, which is particularly important to emerging Life Sciences firms dealing with federal government-mandated standards. ISI's San Francisco office, which opened in 2004, relocated in August to accommodate the growing staff, now twice the size of the original team. The San Diego office opened July 1st. Both offices are supported by ISI's global team of 380 staff members.
ISI's industry leading solutions are pragmatic and scalable and take into consideration regulatory agencies in varying regions, and changing electronic submission requirements. Additionally, their portfolio of proven tools and templates supports these flagship products, eCTDXPress(R), an automated regulatory submission system that meets the FDA's electronic Common Technology Document (eCTD) standard and ISIPublisher(R), a multi-format publishing system for international regulatory submissions. Both products are further enhanced through a flexible technology foundation: the ISI Solutions Platform, a Microsoft's .NET architecture that provides a reliable foundation for integration and interoperability. Over the past several years .NET has demonstrated an ability to help Life Science organizations reduce costs through faster integration and improve quality while streamlining their drug development lifecycle.
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 nearly 1,000 electronic submissions and over 400 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 http://www.imagesolutions.com.
Lisa Meyer Kurt Rossler
Director, Global Marketing M Booth & Associates
973-560-0808 x. 217 212 481-7000
|SOURCE Image Solutions, Inc.|
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