At Mindlance our Pharmacovigilance and Drug Safety group is dedicated solely to collecting, interpreting and reporting safety events on behalf of clients after their products are approved for marketing covering a broad spectrum of therapeutic areas. Our services span the life cycle of marketed medical products, including pharmaceuticals, biologics and medical devices.

Our resources have extensive experience in :

• Individual Case Safety Reports (ICSRs)
• Periodic Safety Update Reports (PSURs)
• Annual Safety Reports (ASRs)
• Summary Bridging Reports (SBRs)
• Scientific Literature Surveillance
• SAE Management and Reconciliation
• Case Narrative Writing
• Medical Coding
• Safety Signal Detection
• Epidemiology Consultation
• Risk Management
• Regulatory Consultation