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Regulatory compliance

/ RMP

Risk Management Module

Data-centric risk management — the EU RMP as governed output, not starting point.

Salvus RMP replaces the document-centric model with a structured risk management system: safety concerns, PV activities and risk minimisation measures are governed data objects from which compliant EU RMP documents are generated. A change to a safety concern propagates through the entire document automatically.

Key capabilities

Safety Concern Library

EU RMP Authoring Workspace

PV Plan & Study Tracking

Risk Minimisation Measures

Effectiveness Evaluation

Global Market Variants

GVP V / XVI

22 modules

Full risk management lifecycle

EU + UK + J-RMP

Market variants

L0–L4

Automation levels, HITL gated

What it does

All the capability, none of the complexity.

Salvus RMP replaces the document-centric model with a structured risk management system: safety concerns, PV activities and risk minimisation measures are governed data objects from which compliant EU RMP documents are generated. A change to a safety concern propagates through the entire document automatically.

01 Safety Concern Library

Important identified risks, potential risks and missing information managed as governed data objects — not text in a document — with MedDRA coding and evidence provenance.

02 EU RMP Authoring Workspace

Complete EMA template Rev 2.0.1 structure (Parts I–VII, SI–SVIII, Annexes 1–8). Auto-generated sections are provenance-locked — changes require an override flag.

03 PV Plan & Study Tracking

Category 1/2/3 studies managed as commitments with milestone tracking. PASS protocols and report timelines tracked to Annex 2 tabulation automatically.

04 Risk Minimisation Measures

Routine and additional RMMs mapped per safety concern. aRMM material authoring, version control, translation, distribution and acknowledgement evidence all in one module.

05 Effectiveness Evaluation

GVP Module XVI process and outcome indicators defined per measure, captured over time and synthesised into effectiveness evaluation reports.

06 Global Market Variants

Core RMP maintained once; UK, J-RMP, Canada, Australia and other market variants generated as controlled deltas. Local teams review only what changed.

07 AI-Assisted Authoring

Legacy RMP extraction from uploaded documents with ≥ 90% acceptance target. Consistency checker catches contradictions at every review gate.

08 Signal-to-Risk Integration

Validated signals from Signum arrive as structured proposals in the safety concern library. Impact assessment workflow records the complete evidence chain.

How it works

From day one to every day after.

A typical journey through Risk Management Module — from onboarding to steady-state operations.

1

2

3

4 Safety concern management

Concerns are proposed, assessed, classified and approved by the risk management team. Every change audit-trailed; reclassification requires justification.

RMP authoring

Structured data auto-populates the mandatory sections. Authors write the scientific narrative with AI assistance and inline EMA guidance.

Review & approval

Multi-step workflow with role-based approval. QPPV or deputy e-signs the final version. Submission-ready Word and PDF generated from the approved dataset.

Post-approval lifecycle

Signal outcomes, PASS results, effectiveness data and regulatory updates feed back — triggering a new RMP update cycle when warranted.

See It in Action

Watch Risk Management Module in action.

A guided walkthrough of the key workflows — built for Pharmacovigilance teams who need to see it to believe it.

.

How to add your demo video

1. Upload the Risk Management Module demo to YouTube.

2. Copy the video ID from the URL — the part after watch?v=

3. In the HTML above, find: data-vid="PASTE_VIDEO_ID_HERE"

4. Replace PASTE_VIDEO_ID_HERE with your actual video ID.

5. Save & deploy — the play button handles the rest automatically.

Integrations

Connects where you need it to.

Risk Management Module is designed to work with the rest of the Salvus platform — and with third-party systems your team already uses.

Regulatory compliance

/ RMP

Risk Management Module

Data-centric risk management — the EU RMP as governed output, not starting point.

Key capabilities

Safety Concern Library

EU RMP Authoring Workspace

PV Plan & Study Tracking

Risk Minimisation Measures

Effectiveness Evaluation

Global Market Variants

GVP V / XVI

22 modules

Full risk management lifecycle

EU + UK + J-RMP

Market variants

L0–L4

Automation levels, HITL gated

What it does

All the capability, none of the complexity.

01

Safety Concern Library

Important identified risks, potential risks and missing information managed as governed data objects — not text in a document — with MedDRA coding and evidence provenance.

02

EU RMP Authoring Workspace

Complete EMA template Rev 2.0.1 structure (Parts I–VII, SI–SVIII, Annexes 1–8). Auto-generated sections are provenance-locked — changes require an override flag.

03

PV Plan & Study Tracking

Category 1/2/3 studies managed as commitments with milestone tracking. PASS protocols and report timelines tracked to Annex 2 tabulation automatically.

04

Risk Minimisation Measures

Routine and additional RMMs mapped per safety concern. aRMM material authoring, version control, translation, distribution and acknowledgement evidence all in one module.

05

Effectiveness Evaluation

GVP Module XVI process and outcome indicators defined per measure, captured over time and synthesised into effectiveness evaluation reports.

06

Global Market Variants

Core RMP maintained once; UK, J-RMP, Canada, Australia and other market variants generated as controlled deltas. Local teams review only what changed.

07

AI-Assisted Authoring

Legacy RMP extraction from uploaded documents with ≥ 90% acceptance target. Consistency checker catches contradictions at every review gate.

08

Signal-to-Risk Integration

Validated signals from Signum arrive as structured proposals in the safety concern library. Impact assessment workflow records the complete evidence chain.

How it works

From day one to every day after.

A typical journey through Risk Management Module — from onboarding to steady-state operations.

1

2

3

4

Safety concern management

Concerns are proposed, assessed, classified and approved by the risk management team. Every change audit-trailed; reclassification requires justification.

RMP authoring

Structured data auto-populates the mandatory sections. Authors write the scientific narrative with AI assistance and inline EMA guidance.

Review & approval

Multi-step workflow with role-based approval. QPPV or deputy e-signs the final version. Submission-ready Word and PDF generated from the approved dataset.

Post-approval lifecycle

Signal outcomes, PASS results, effectiveness data and regulatory updates feed back — triggering a new RMP update cycle when warranted.

See It in Action

Watch Risk Management Module in action.

A guided walkthrough of the key workflows — built for Pharmacovigilance teams who need to see it to believe it.

.

How to add your demo video

Integrations

Connects where you need it to.

Risk Management Module is designed to work with the rest of the Salvus platform — and with third-party systems your team already uses.

ICSR

Case evidence for safety concerns

Signum

Signal outcomes trigger RMP proposals

Crypta

Literature evidence for safety sections

Reg Intelligence

Regulatory updates trigger section reviews

Compliant with

GVP Module V (Rev 2)

GVP Module XVI (Rev 3)

EMA RMP Template Rev 2.0.1

FDAAA 505-1 (REMS)