WASHINGTON, DC -- (Marketwire) -- 06/08/10 -- EXTEDO, a key eRegulatory Affairs solutions provider for life sciences firms, today announced the availability of PcVmanager 1.3, a major new release of the leading drug safety software management solution based on E2B and MedDRA standards.
PcVmanager enables users to classify, create, review, submit, and maintain Pharmacovigilance data and adverse reports. The product manages the life cycle of mandatory SUSAR and ICSR reports to the EMA (European Medicines Agency) and the NCAs, as well as all reported Serious Adverse Events (SAE) for an overall safety re-evaluation.
PcVmanager version 1.3 contains the following new features and enhancements:
EXTEDO, a Microsoft Gold Partner, will also be demonstrating the integration of their eCTDmanager Suite with the Microsoft SharePoint 2010 business collaboration platform.
The seamless integration of Microsoft SharePoint 2010 and EXTEDO eCTDmanager Suite helps life sciences firms manage the entire lifecycle of their regulatory documents. With the integrated solution life sciences firms can view, review, compile, and publish information by using the standard SharePoint 2010 interface at the DIA Annual Meeting.
Key benefits that firms will derive from the integrated solution are -- reduced time to market, increased collaboration between different departments, and improved compliance with regulatory requirements.
"This new version of PcVmanager is available now and enables drug safety professionals to be prepared in advance for the new EMA business rules which go into effect on July 1st," stated Tore Bergsteiner, CEO for EXTEDO. "The new enhancements that we have made to PcVmanager make the product even easier to use and more flexible."
EXTEDO life sciences industry experts will be demonstrating PcVmanager 1.3 and the new SharePoint 2010 solution in booth 2000 at the 46th DIA Annual Meeting, in Washington D.C., on June 14-16, 2010.
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, Label 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.
For more information visit www.extedo.com.
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