ISI Releases Next Major Software Version for Japanese Market to Address Fast Move to Paperless Environment for Regulatory Submissions

WASHINGTON--(BUSINESS WIRE)--As Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) moves aggressively to create a stable infrastructure to accept regulatory submissions in the electronic Common Technical Document (eCTD) format, ISI, a market-leading software and services vendor in Japan with 45 percent market share, today announced the availability of the newest version of its Regulatory Solutions Suite (RSS) to accommodate the specialized requirements of the Japanese market. The improved RSS product, which will be implemented in partnership with CAC Corporation, offers new features and functionality and an enhanced Japanese user interface to give companies greater flexibility to manage eCTD and paper submissions.