Risk Management Plans Pharmacovigilance (RMPs): Proactive Risk Control for Regulatory Success
RMPs often fail because:
Risks are not clearly justified
Measures are generic
Effectiveness indicators are weak
Updates lag behind real-world data
Health Authorities expect RMPs to actively control risk, not just describe it.
How GPLACO SOLUTIONS Solves It
We design regulator-ready RMPs that integrate:
Signal outputs
Benefit-risk assessments
Risk minimization measures
Measurable effectiveness indicators
Our RMPs are:
✔ Evidence-driven
✔ Lifecycle-managed
✔ HA-ready
Aligned with:
ICH, GVP Module V, EU RMP & REMS expectations
Results Our Clients Achieve
✔ Faster regulatory acceptance
✔ No critical deficiencies
✔ Clear linkage between signals and risks
✔ Sustainable risk governance
RMPs should de-risk your product — not delay approvals.