OTTOBRUNN, GERMANY — (Marketwire) — 07/14/11 — , a key eRegulatory Affairs solutions provider for life sciences firms, today announced that it has introduced a hosted version of . PcVmanager is a drug safety management software solution that enables executives at life sciences firms to classify, create, review, submit, and maintain Pharmacovigilance data and adverse event reports. The hosted version of PcVmanager has been successfully deployed at several life sciences firms.
EXTEDO PcVmanager manages the life cycle of mandatory Suspected Unexpected Serious Adverse Reaction (SUSAR) and Individual Case Safety Report (ICSR) reports to the European Medicines Agency (EMA), the National Competent Agencies (NCAs) and the FDA via an integrated E2B gateway, as well as all reported Serious Adverse Events (SAE) for an overall safety re-evaluation. A variety of other regions are supported through different report formats, such as MedWatch and CIOMS.
“Our hosted PcVmanager offering is a cost effective solution for firms that have limited IT and testing resources,” stated , Managing Director for EXTEDO. “We take care all of the necessary hardware and software and also pre-validate the solution.”
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.
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Media Contact:
Michael Kane
EXTEDO
Tel: 1-978-257-2179
Email:
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