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Our Solutions

Tailored Solutions. Built Around Your Needs.

From establishing new capabilities to strengthening existing systems and managing defined functions, VIGIVANCE provides flexible engagement models aligned with organisational objectives, regulatory requirements and operational priorities.

Flexible Engagement

Build · Transform · Extend · Outsource

We work with Marketing Authorisation Holders, pharmaceutical manufacturers, and distributors to build, transform, extend, or outsource PV operations, providing exactly the level of support required, without unnecessary complexity or a one-size-fits-all model.

BUILD

Establish. Implement. Operationalise.

Build new capabilities, systems and compliance frameworks from the ground up with the processes, governance and expertise required for sustainable operation.

PV System SetupSOP FrameworkPSMFQPPV/LQPPV ModelSafety DatabaseReporting WorkflowsGovernanceTraining
TRANSFORM

Assess. Remediate. Strengthen.

Evaluate existing processes and systems, identify gaps, implement targeted remediation and strengthen compliance, quality and operational performance.

GAP AssessmentPV System AssessmentSOP RemediationCAPAProcess OptimisationQuality ManagementAudit ReadinessInspection Readiness
EXTEND

Augment. Integrate. Accelerate.

Extend internal capabilities with specialised scientific, regulatory and operational expertise to address capacity or capability requirements.

QPPV/LQPPV SupportMedical ReviewICSR OperationsLiterature MonitoringSignal ManagementAggregate ReportingRegulatory SupportMedical Writing
OUTSOURCE

Delegate. Govern. Deliver.

Transfer defined activities, processes or complete functions to VIGIVANCE through a structured, quality-controlled service model with clear accountability and oversight.

End-to-End PVICSR ManagementLiterature SurveillanceAggregate ReportingQPPV ServicesRegulatory OperationsMedical WritingClinical Support

A Team You Can Rely On

Every engagement is backed by qualified pharmacovigilance, regulatory and medical professionals working to the same quality standards, documented processes, and scientific rigour, whatever the size or shape of the engagement.

Meet VIGIVANCE →
Built Around Your Reality

You Can Engage VIGIVANCE For

Whether you are launching a new product, entering a new market, managing a growing portfolio, facing increased case volumes, strengthening compliance, addressing a remediation requirement, or looking for a long-term PV partner, our model adapts to your situation.

A Specific Activity

When you need expertise for a defined PV requirement.

A Defined Project

When you need focused support with a particular deliverable or programme.

Additional Capacity

When your internal team needs reliable operational support.

An Integrated PV Function

When you want a partner to manage defined PV responsibilities on an ongoing basis.

End-to-End PV Outsourcing

When you prefer to place the operational management of your PV activities with a specialist partner.

Our solutions can be delivered through: Project-Based Support · Functional Support · Dedicated Resources · Long-Term Outsourcing

Support Across the Product Lifecycle
DevelopmentClinicalRegulatoryLaunchPost-Marketing

Discuss Your Requirement.

Tell us what you need. We'll define the right approach.