Pharmacovigilance

Risk Management Plans (RMP)

Risk Management Plans define known and potential risks and the measures used to minimize them. Viltis supports RMP development, updates, and alignment with signal management and labeling.

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Practice areaPharmacovigilance
Typical needCapability support for regulated programs
EngagementConsulting, augmentation, or hybrid
Related pathPharmacovigilance

The client situation

When organizations typically need this capability.
  • Initial MAA / NDA support needs
  • Major safety label changes
  • Authority questions on risk minimization

How Viltis helps

Structured support, end to end

  1. 01

    Step 1

    RMP drafting support

  2. 02

    Step 2

    Risk minimization design

  3. 03

    Step 3

    Cross-functional workshops

  4. 04

    Step 4

    Update control processes

Risk Management Plans define known and potential risks and the measures used to minimize them. Viltis supports RMP development, updates, and alignment with signal management and labeling.

Typical deliverables

What engagement can produce

RMP versions

Annex packages

Effectiveness evaluation frameworks

FAQ

Common questions

US REMS as well?

We can coordinate REMS-related discussions when they interact with global risk management strategy.

Related proof

Manufacturing, Quality and Process Team

Recommissioning and qualifying a manufacturing site to produce COVID-19 test kits at scale.

Read the case study →

Viltis provides consulting and resourcing for compliance readiness and operational support. We do not issue certifications or act as an accredited certification body.

Need support with Risk Management Plans (RMP)?

Discuss this requirement with our team - scope, timeline, and delivery model.

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