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.
“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”
ISI has enhanced its regulatory electronic publishing and paper
publishing products and services to create one of the industrys 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 companys
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 its important to work with a partner that
exhibits industry expertise, provides deep resources, and has an
established market presence and thats 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. ISIs
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 ISI
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
recognised charitable organisations. For more information, visit the
company website at www.imagesolutions.com

Source: Business Wire