Pharmacovigilance Documentation

PV Services can prepare the pharmacovigilance documents required by the Regulatory Authorities which include:

• Standard Operating Procedures (SOPs)
• Summary of Pharmacovigilance Systems (SPSs)
• Risk Management Plans (RMPs)
• Clinical Trial Annual Safety Reports (ASRs)
• Named patient / compassionate use program Annual Safety Reports
• Periodic Safety Update Reports (PSURs)