Compliance & Standards
Pharmacovigilance
GVP-aligned safety systems, case processing, aggregate reporting, and audit readiness.
Regulatory landscape
Standards and frameworks in this category
Each topic links to an existing Viltis service page describing implementation, assessment, and remediation support.
Aggregate Safety Reporting
DSUR, PBRER, and PSUR planning and authoring support.
Pharmacovigilance System Master File
PSMF structure, maintenance, and inspection readiness.
Risk Management Plans
RMP development and risk minimization planning.
ICSR Management
Global case processing aligned with ICH E2B(R3).
Signal Detection & Risk Management
Signal detection workflows and benefit-risk management.
PV Audit Readiness
Preparation for PV inspections and internal audits.
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Discuss pharmacovigilance compliance
Share your current controls, upcoming audits, or remediation priorities.