SOURCE: EXTEDO

September 13, 2010 08:00 ET

EXTEDO Showcasing Cost Effective Pharmacovigilance Solution at Pacific Drug Safety Summit

WEST CHESTER, PA--(Marketwire - September 13, 2010) -  EXTEDO, a key eRegulatory Affairs solutions provider for life sciences firms, today announced that they would be demonstrating their PcVmanager solution at the Pacific Drug Safety Summit, September 23-24, 2010 in Burlingame, CA.

EXTEDO PcVmanager is a drug safety management software solution based on the E2B and MedDRA standards that enables users to classify, create, review, submit, and maintain Pharmacovigilance data and adverse event reports.

EXTEDO PcVmanager 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 also supports adverse events reporting to the FDA.

"PcVmanager enables drug safety professionals at Life Sciences firms to manage all of their Pharmacovigilance reports with a single solution," stated Harv Martens, Vice President of Operations for North America and Japan for EXTEDO. "It is the most complete and cost effective solution available in the market."

About EXTEDO

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, 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 the worldwide leader in each of its areas of operation.

For more information visit www.extedo.com.

All trade names, trademarks, and service marks are the rightful property of their respective owners.

Contact Information

  • Media Contact:
    Michael Kane
    EXTEDO
    Tel: +1-978-257-2179
    Email: Email Contact