Tokyo and Frankfurt/Main, 29 August 2016 // Following the 2nd International Symposium of the Japan eCTD Society on May 24, 2016 in Tokyo, the partner companies Digital Media System and LORENZ initiated a taskforce to work on a knowledge base covering the specific items relating to eCTDs submitted to PMDA, the regulatory agency for pharmaceuticals and medical devices in Japan.
The Japanese eCTD's technical aspects are defined by the written specification and the official regional schema. These are addressed by established software solutions like LORENZ docuBridge. However, the taskforce went even further and investigated aspects of content section, validation and application submittal procedure that are specific to Japanese regulations.
This knowledge base is now an essential resource for global pharmaceutical companies on Japanese eCTDs. Even though a global regulatory affairs department can process/publish eCTD submissions for many regions with one centralized team, this approach is usually not successful for Japan.
Hiroji Emoto, President and CEO of Digital Media System Co., Ltd. noted that "with docuBridge we can utilize our specialized knowledge to provide eCTD service and consultancy to our customers in Japan very efficiently."
"Our joint knowledge that we have assembled over one decade enables us to combine our software with the services appropriate to specific regional requirements - a reason why we have an exclusive partnership with Digital Media System for Japan. This is also the reason why all our agreements with other global partners always exclude Japan," said Wolfgang Witzel, President of LORENZ Life Sciences Group.
People interested to learn more about the distinct items related to eCTD submitted to PMDA may contact Digital Media System and LORENZ directly.
About LORENZ Life Sciences Group
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ's solutions are geared specifically for submission assembly, review, publishing, validation and management. LORENZ docuBridge is the most widely used eCTD submission management system for U.S., European and Japanese formats among many others, and is popular with regulatory agencies and industry alike. With close to 600 paid installations in over 30 countries, LORENZ has a strong worldwide customer base.
About Digital Media System Co., Ltd.
Digital Media System Co., Ltd. (DMS) is the exclusive distributor of LORENZ docuBridge in Japan. Beside the submission management system, DMS also established expertize among partners to provide a Premium eCTD Compilation Service for eCTD applications to the Japanese authority. For further information please contact Telephone +81-3-5550-5595 or Web: www.dms-jp.com.