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EXTEDO Announces the Availability of a New Solution to Help Life Sciences Firms Comply With New European Drug Safety RegulationsEXTEDO MPDmanager Supports New XEVMPD Submission Standard (April 17, 2012)
OTTOBRUNN, GERMANY -- (Marketwire) -- 04/17/12 -- EXTEDO, a key eRegulatory Affairs solutions provider for life sciences firms, today announced the availability of MPDmanager, a recent addition to the EXTEDOsuite that enables life sciences firms to comply with the new pharmacovigilance (XEVMPD and IDMP) legislation announced by the European Medicines Agency (EMA). The new XEVMPD regulation, which goes into effect on July 2, 2012, mandates that life sciences firms use a globally harmonized exchange format to manage drug safety product information. MPDmanager 1.0 is available now. For pricing and ordering information contact EXTEDO at [email protected].
EXTEDO MPDmanager is an application that enables companies to manage and submit all regulatory data in the format requested by the XEVMPD and IDMP. It allows companies to easily enter, import and share all relevant regulatory data requested by the XEVMPD. The MPDmanager is part of the EXTEDO Registration Management Suite, and shares the Records Master Data Management layer with other EXTEDOsuite components or third party products.
"The new regulations are creating compliance challenges for life sciences firms," stated Tore Bergsteiner, CEO for EXTEDO. "MPDmanager is an intuitive solution that enables life sciences firms to immediately start submitting all of their product information in the new format specified by EMA."
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.
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