Our Pharmacovigilance Consulting service helps pharmaceutical companies build and optimize their drug safety systems. We design PV systems, implement signal detection processes, develop risk management plans, and support regulatory compliance. From ICSR processing to PSUR preparation, we ensure your safety system meets global regulatory requirements.
How our pharmacovigilance consulting service delivers value to your organization.
Comprehensive pharmacovigilance system design including ICSR processing, case management, and reporting workflows.
Signal detection and management process design including statistical methods, review procedures, and escalation protocols.
Risk management plan (RMP) development aligned with EMA and FDA requirements.
PV regulatory compliance support including PSUR, PADER, DSUR preparation and submission.
Comprehensive deliverables that provide actionable intelligence for your team.
A structured methodology that delivers results in four phases.
Assess current PV system, capabilities, and compliance status.
Design or optimize PV system including processes, workflows, and technology.
Support PV system implementation including training and validation.
Ensure ongoing compliance with global PV regulations and reporting requirements.
We cover FDA (21 CFR 314.80, 314.98), EMA (GVP modules), ICH (E2E, E2D, E2B), and country-specific PV requirements across major markets.
Yes, we support PV system implementation including safety database selection, validation, process rollout, and team training.
Yes, we evaluate PV service providers, support selection, and establish governance frameworks for outsourced PV operations.
Risk framework, risk register, and mitigation planning for pharmaceutical companies.
Learn moreSunshine Act, anti-bribery, and transparency reporting compliance programs for pharmaceutical companies.
Learn moreGDPR, HIPAA, and data governance for pharmaceutical companies handling health data.
Learn moreConnect with our team to discuss how our pharmacovigilance consulting service can support your goals.
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