Image Solutions, a provider of software and services for the life sciences industry, has announced that its Tianjin, office was granted ISO 27001:2005 certification by the International Organization for Standardization.
ISI received the accreditation for meeting Information Security Management Systems standards in the areas of Regulatory Operations and Submission Processes for life sciences organizations.
Jinsoo Kim, president and chief executive officer of ISI stated that downward cost pressure, particularly in R&D, has pharmaceutical companies of all sizes looking for the combination of China pricing with the reliability of a proven domestic he added that more than ever, firms were asking ISI to manage their entire regulatory submissions because it removes the steep learning curve of the global regulatory landscape.
The Tianjin audit was conducted by Det Norske Veritas, a leading global provider of risk management consulting and certification solutions.
ISI now has more than half of its 400 global employees involved in regulatory operations in offices around the world, namely in the United States, Germany and China. The Tianjin, China, office focuses mainly on document processing, and is expected to help ISI double its processing of electronic Common Technical Document: the preferred format for electronic regulatory submissions, over the next year.
Most of ISI eCTD’s work — about 90% — entails submissions to the United States FDA, but with ongoing global efforts to harmonize eCTD regulatory standards, ISI is helping clients prepare submissions in an expanding list of countries. In the European Union, all national competent authorities must be capable of receiving eCTD-only submissions for Mutual Recognition, Decentralized, and Nationally-registered products by the beginning of 2010.
In addition to regulatory software, ISI provides medical writing; regulatory consulting; biometrics, implementation/IT services; electronic submission outsourcing; and education services for life sciences and biotechnology companies around the world.