Pharmacovigilance & Drug Safety Software Solutions
EXTEDO is the only vendor on the market that is able to cover the complete regulatory landscape, including Product Registration Planning & Tracking, Submission Publishing & Lifecycle Management, Pharmacovigilance Management.
Pharmacovigilance and drug safety monitoring are vitally important for medicinal product developers, license holders and clinical investigators. In addition to their duty to protect public health, increasingly tight regulation and the potential for substantial fines provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for pharmacovigilance / drug safety.
As one of the leading providers of software solutions for the life science industry, EXTEDO has collaborated with regulatory authorities around to world and developed a powerful pharmacovigilance / drug safety product designed to meet the needs of life science organizations.
PcVmanager is a drug safety management solution based on the E2B and MedDRA industry data standards. It enables you to classify, create, review, submit, and maintain pharmacovigilance data and adverse event reports.