January 18, 2011 11:52 ET

Beijing Second Pharmaceutical Selects EXTEDO eCTDmanager Suite to Manage Regulatory Submissions

EXTEDO Customer Base Expands Into the Chinese Market

OTTOBRUNN, GERMANY--(Marketwire - January 18, 2011) - EXTEDO, a key eRegulatory Affairs solutions provider for life sciences firms, announced today that Beijing Second Pharmaceutical Co., Ltd. (BSPC), one of China's leading pharmaceutical companies, has selected the eCTDmanager Suite™ to manage regulatory submissions.

The EXTEDO eCTDmanager Suite provides Beijing Second Pharmaceutical with an easy-to-use electronic management solution for building, viewing, validating, and publishing compliant submissions that meet global regulatory specifications.

"Since we will distribute our products to USA, EU and other outside markets, we need a flexible submission management solution," said Wenfeng Wang, Vice General Manager of Research and Development for Beijing Second Pharma. "One important reason why we selected EXTEDO was that their solution enables us to easily submit NDAs, eNDAs, eCTD and hybrid submissions with a single tool."

"This is a very significant customer win for us," stated Martin Schmid, Managing Director of EXTEDO. "With Beijing Second Pharma, EXTEDO has entered an emerging Life Science market that is growing quickly. This project confirms our global growth strategy and will enable us to close additional business in the APAC region."


EXTEDO is the key solutions and services provider in the field of eRegulatory Affairs. The complete EXTEDOsuite is unique in all that it covers: Product Registration Planning & Tracking, Submission Management, Pharmacovigilance Management, Labelling 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 the worldwide leader in each of its areas of operation.

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