OTTOBRUNN, GERMANY--(Marketwire - August 23, 2011) - EXTEDO, a key eRegulatory Affairs solutions provider for life sciences firms, today announced that Fuji Xerox has selected the eCTDmanager Suite™ to manage regulatory submissions among outsourcing services for its customers.
The EXTEDO eCTDmanager Suite provides Fuji Xerox with an easy-to-use electronic management solution for building, viewing, validating, and publishing compliant submissions that meet both regional Japanese regulatory specifications and global specifications.
"The requirements for regulatory submissions vary by country/region," said Taiichi Hatabu, general manager, at Fuji Xerox. "The EXTEDO eCTDmanager Suite provides us with a powerful solution that enables us to accommodate electronic, paper, or hybrid submissions. It adds value to our services."
"With the Fuji Xerox customer win we have entered into a key market for our solutions," stated Martin Schmid, Managing Director for EXTEDO. "This is another major win in the APAC region in 2011, and it will definitely help us expand our customer base in that area of the world."
EXTEDO is the key software and service solutions provider in the field of Regulatory Information Management. The complete EXTEDOsuite is unique in all that it covers within eRegulatory Affairs: Product Registration Planning & Tracking, Submission Management, Pharmacovigilance Management, Labeling Management and Document Management.
EXTEDO provides configurable off-the-shelf products, as well as customized and integrated solutions. EXTEDO also provides EURS is Yours, the validation, review and approval system for the EMA and more than 25 Regulatory Authorities worldwide.
Today EXTEDO serves more than 700 customers in 57 countries ranging from small companies with less than 25 employees to large multi-national organizations. EXTEDO operates in the following markets for human, veterinary and crop protection: Life sciences, including pharmaceutical, biotech and biopharma, generics, homeopathics and medical devices, healthcare and public sector. EXTEDO is recognized as one of the worldwide leaders in each of its areas of operation.
For more information visit www.extedo.com.
About Fuji Xerox
Fuji Xerox Co., Ltd. is a 75-25 joint venture between FUJIFILM Holdings Corporation and Xerox Corporation (U.S.A.) that develops, manufactures and markets world-class office and publishing equipment/systems, digital colour/monochrome multifunction devices, as well as document management software, solutions and services in Japan and the Asia-Pacific region. It also manufactures digital copiers, multifunction devices and printers for worldwide distribution. Founded in 1962 with its headquarters in Tokyo, Japan, the Company currently employs more than 42,000 people globally, and has more than 70 domestic and overseas affiliates and sales subsidiaries.
All trade names, trademarks, and service marks are the rightful property of their respective owners.