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 standardised 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 specialised 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 authorisations, 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.