Castle Pharmacovigilance Ltd provides pharmacovigilance consultancy services for the pharmaceutical and biopharmaceutical industry.
Castle Pharmacovigilance provides quality, cost effective pharmacovigilance support, both to assist companies in meeting their general pharmacovigilance obligations and also for specific projects.
Castle PV can help in areas such as:
• Provision of EU Qualified Person for Pharmacovigilance (QPPV) services
• Establishment of new pharmacovigilance systems and processes
• Development and maintenance of Pharmacovigilance System Master Files
• Process review and improvement to assist in achieving and maintaining regulatory compliance
• Pharmacovigilance training
• Preparation and maintenance of Standard Operating Procedures
• Support for Individual Case management activities
• Periodic Risk Benefit Update Report preparation
• Preparation of Safety Data Exchange Agreements
• Pharmacovigilance and Risk Management Planning
• Inspection and Audit preparation and management
• Pharmacovigilance Quality monitoring and Corrective and Preventative Action development and implementation