Service Capabilities
ICSR (Individual Case Safety Report) Management
End-to-end case processing services, including intake, triage, data entry, quality review, medical assessment, and regulatory submission of spontaneous, solicited, literature, and clinical trial reports. Our team ensures full compliance with global regulatory requirements (FDA, EMA,
MHRA, CDSCO, PMDA, TGA), accurate MedDRA coding, and high-quality narrative writing to support reliable and timely safety reporting.
Aggregate Safety Reporting
Complete preparation and submission of PBRERs, PSURs, DSURs, and ACO reports featuring robust benefit–risk evaluations, clear safety signal analyses, and full alignment with global
regulatory expectations. Our expertise ensures high-quality documentation, consistent reporting standards, and on-time delivery across all regional regulatory timelines.
Signal Detection and Risk Evaluation
Advanced signal detection capabilities leveraging statistical methodologies, epidemiological assessment, literature surveillance, and trend analysis. We deliver clear scientific interpretation,
evidence-based risk evaluations, and regulatory-ready recommendations modeled on PRAC best practices. Our comprehensive documentation supports both internal safety governance and external submissions to health authorities.
Risk Management Plans (RMP) Development
Comprehensive authoring, update management, and lifecycle maintenance of EU-RMPs, US REMS, and country-specific risk minimization plans. We also develop and support implementation of educational materials, risk communication tools, and effectiveness evaluation strategies to ensure compliance and optimized patient safety outcomes.
Global Safety Surveillance
Proactive monitoring of global scientific literature, safety database trends, and regulatory intelligence to identify emerging risks and maintain continuous compliance across international markets. Our structured surveillance approach supports timely signal recognition, informed decision-making, and robust patient safety oversight.
Compliance monitoring, Audit Support, and Continuous Improvement
Holistic support for pharmacovigilance audits and regulatory inspections, including SOP development, CAPA implementation, deviation management, and process standardization in line with Good Pharmacovigilance Practice (GVP). We monitor compliance through robust performance metrics and KPIs such as case processing timeliness, data quality scoring, query
turnaround time, and CAPA closure rates. Our structured, data-driven approach strengthens
inspection readiness, enhances quality system maturity, and promotes continuous operational
improvement.
Explore other services
