Pharmacovigilance Legislation & IMplementaton

Cox PharmaConsulting can provide you with a consultant specialising in pharmacovigilance solutions to work alongside your operational team, reducing their burden, enabling them to continue to meet the requirement of daily PV regulatory obligations, and raising your confidence that you can move forward with compliant, practical solutions.

· Review and upgrade your Pharmacovigilance Systems (Gap Analysis, Implementation projects, full or part service provider selection, etc.)

· PV System Master File (PSMF)

· SOP & template review &/or authorship

· Safety Data Exchange Agreements (SDEA)

· Database/systems upgrade support

· On-site Training & Awareness Programmes

· Other Pharmacovigilance Projects