EXTEDO Extends Product Family to Help Life Sciences Firms Comply With New European Drug Safety Regulations
Published: Jan 24, 2012
OTTOBRUNN, GERMANY--(Marketwire - January 24, 2012) - EXTEDO, a key eRegulatory Affairs solutions provider for life sciences firms, today announced a new solution -- MPDmanager™ -- to help life sciences firms comply with the new pharmacovigilance legislation (EVMPD) announced by the European Medicines Agency (EMA). The new EVMPD 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.
To comply fully with this new regulation firms will undoubtedly face challenges. It will be required that life sciences firms submit all product information in a new XEVPRM format for all authorized products in Europe. The XEVPRM format exceeds in volume and content the current EVMPD format.
EXTEDO MPDmanager is an application that enables companies to manage and submit all regulatory data in the format requested by the EVMPD standard. It allows companies to easily enter, import, share and submit relevant regulatory data. The MPDmanager will be part of the EXTEDO Registration Management Suite, and shares a Master Data Management layer with other EXTEDOsuite components or associated third party products. This new solution will be made available for selected clients and partners in the first quarter of 2012.
To help Life Sciences firms prepare for the new regulations EXTEDO has already been running a series of webinars and seminars that provide details about the new EVPMD standard and strategies firms can employ to meet the compliance challenges.
"The deadline to comply with the new regulations is coming up quickly," stated Tore Bergsteiner, CEO for EXTEDO. "MPDmanager is a flexible off-the-shelf solution that enables applicants to implement and comply with the EVMPD legislations."
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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