About Us
Why our team
Why our team
Why our team
Our team of global experts in Pharmacovigilance can support and guide you from early clinical development through successful marketing approval across North America, Europe, Latin America, Australia/NZ and Japan.
How We Help
Why our team
Why our team
From AE case processing, signal detection, CSRs through PSURs / RMPs, PSMF, Risk Management, and everything in between - our team can provide a complete PV solution. Do you need help with auditing and oversight of your vendors and ensuring compliance with GVP, and applicable local regulations and guidance? We can provide your QPPV, deve
From AE case processing, signal detection, CSRs through PSURs / RMPs, PSMF, Risk Management, and everything in between - our team can provide a complete PV solution. Do you need help with auditing and oversight of your vendors and ensuring compliance with GVP, and applicable local regulations and guidance? We can provide your QPPV, develop and maintain your CCDS and local labels, RMPs, and PBRERs to ensure your PV System is robust and compliant.
Experience the Difference
Experience the Difference
Experience the Difference
Our depth of experience in global PVG and process/vendor management allows our auditing team to quickly identify issues, identify solutions and provide a remediation plan. We've developed a proprietary "PVG Touchpoints" program that identifies and maps every task across your organization that supports or "touches" PVG. We identify and
Our depth of experience in global PVG and process/vendor management allows our auditing team to quickly identify issues, identify solutions and provide a remediation plan. We've developed a proprietary "PVG Touchpoints" program that identifies and maps every task across your organization that supports or "touches" PVG. We identify and provide the procedures/tools needed to support each touchpoint. We have a turnkey vendor oversight program that tracks Key Metrics and includes CAPA management.
Our Leader
Experience the Difference
Experience the Difference
Our CEO, Shelly Goodman, has over 25 years of experience in Global Pharmacovigilance and Development, and has worked for small and emerging startup companies, academia, the FDA, and large pharma/biotech as well as AROs and CROs.