ISI Helps Pharmaceutical Companies In ASEAN Region Meet Standardized Regulatory Submission Requirements

ISI Helps Pharmaceutical Companies In ASEAN Region Meet Standardized Regulatory Submission Requirements

Full Suite of Products and Services Navigate Evergreen Regulatory Environment

Whippany, NJ - September 3, 2010 - Last year, the pharmaceutical industry in the Association of Southeast Asian Nations (ASEAN) grew to an unprecedented $187 billion. This persistent growth has prompted regulatory authorities across the region to streamline drug submissions; resulting in the introduction of the ASEAN Common Technical Document (aCTD), a standardized format for transfer of regulatory information similar to accepted formats including electronic Common Technical Document (eCTD) and Non-eCTD electronic Submissions (NeeS). ISI, a market-leading global software and services vendor in the Life Science arena, is expanding its offerings to accommodate the specialized requirements of the ASEAN market and help local companies get submission ready.

ISI has enhanced its regulatory electronic publishing and paper publishing products and services to create one of the industry's most powerful submissions solutions and meet the latest ASEAN requirements. A comprehensive array of products, including ISIRegTracker and ISIPublisher, allows ISI to offer tailored solutions to customers dependant upon their specific needs. ISIRegTracker, for example, manages both submissions and marketing authorizations, providing a total picture of a company's product portfolio for more rapid responsiveness to regulatory authorities and streamlined decision making. The software allows for more effective submission, project and resource planning, ensuring milestones are met and resources are efficiently allocated.

"The new regulatory environment requires us to evolve the way we think about our clinical data and all the assets that are involved in the submission process," says Justine Cheng, Regulatory Specialist at Yung Shin Pharmaceuticals, a Taiwanese manufacturer and ISI client. "To succeed, we know that it's important to work with a partner that exhibits industry expertise, provides deep resources, and has an established market presence - and that's what ISI offers."

Regulatory submissions also require a greater knowledge of changes in regulatory requirements, guidance, and sophisticated new technologies. ISI works closely with customers and regulatory agencies to provide relevant submission services based on core competencies. ISI's Professional Services include medical writing, regulatory consulting and software implementation.

"At ISI we provide an adaptable roadmap that combines the appropriate mix of services and software to help guide them the drug development process and to align their strategies," says Paul Chung, COO at ISI.

In 2007, ISI established a physical presence in the Asian expanse with the opening of a new facility in Tianjin, China ensuring clients in the ASEAN region are receiving the attention and assistance they require in a timely manner.

Tags: Regulatory submissions; pharmaceutical industry; aCTD; Association of Southeast Asian Nations; ASEAN

Suggested links: ISI, Association of Southeast Asian Nations, electronic Common Technical Document (eCTD), ISIRegTracker, ISIPublisher

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 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. For more information, visit the company website at