---
title: "Scaling a Global Pharmacovigilance Model for International Growth"
description: "Discover how QbD Group helped a Spanish pharmaceutical company develop a scalable pharmacovigilance model supporting international growth and regulatory compliance."
url: https://qbdgroup.com/zh-cn/case-studies/scalable-pharmacovigilance-model-global-growth
type: "Case study"
language: zh-cn
published: 2026-05-06
publisher: "QbD Group"
citation: "QbD Group, \"Scaling a Global Pharmacovigilance Model for International Growth\", https://qbdgroup.com/zh-cn/case-studies/scalable-pharmacovigilance-model-global-growth"
---
# Scaling a Global Pharmacovigilance Model for International Growth
> Discover how QbD Group helped a Spanish pharmaceutical company develop a scalable pharmacovigilance model supporting international growth and regulatory compliance.

QbD Group supported a family-owned pharmaceutical company in developing a scalable **pharmacovigilance (PV) strategy** to support international growth across Europe. By evaluating different operational models and defining a future-proof PV structure, the company improved efficiency, reduced operational workload and costs, and ensured continued regulatory compliance across multiple markets.

### About the client

The client is a **family-owned pharmaceutical company** based in Spain with a growing international presence across Europe and other global markets.

## Challenge

### Developing a scalable pharmacovigilance strategy to support international expansion

As the company expanded its activities across **France, Germany, Italy, Portugal, and Spain**, it needed to scale its pharmacovigilance operations in a structured, compliant, and efficient way.

The existing PV setup required evaluation to ensure it could support increasing operational complexity, growing product portfolios, and higher case volumes while remaining aligned with **global regulatory requirements** and industry best practices.

The client also needed clarity on which operating model would provide the best balance between **scalability, operational efficiency, implementation timelines, and long-term cost control**.

## Approach

### Evaluating scalable PV operating models for sustainable growth

QbD Group developed a strategic framework to help the client identify the most future-proof pharmacovigilance operating model for its expanding international footprint.

Our approach included:

- **Assessment of two operating models**, full outsourcing and a hybrid PV model, through a scalability-focused lens.
- **Collection and analysis of key operational inputs** including products, countries, case volumes, medical inquiries, and complaints.
- **Evaluation of the advantages, limitations, costs**, implementation timelines, and milestones associated with each model.
- **Simulation of scalability impact** to assess long-term operational sustainability and growth readiness.
- **Delivery of a tailored proposal** outlining the recommended organizational structure, workflows, and required budget aligned with future expansion plans.

Throughout the project, QbD Group combined pharmacovigilance expertise with strategic operational planning to support informed decision-making and scalable growth.

## Result

### Establishing a scalable and cost-efficient PV framework

The project enabled the client to define a scalable pharmacovigilance model capable of supporting continued international growth while maintaining regulatory compliance.

As a result, the company achieved:

- A **scalable PV operating model** aligned with international regulatory requirements.
- A projected **reduction in workload and operational costs of approximately 20%**.
- **Improved efficiency** through process optimization, standardized workflows, and time-saving measures.
- Delivery of all supporting documentation and the proposed operating model **within the planned timelines**.
- **Increased stakeholder confidence** through QbD Group's demonstrated execution capabilities and pharmacovigilance legislative expertise.

The defined strategy now provides the organization with a robust foundation to scale its pharmacovigilance activities efficiently while supporting long-term international expansion.
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Source: https://qbdgroup.com/zh-cn/case-studies/scalable-pharmacovigilance-model-global-growth — © QbD Group. Quote freely with attribution and a link back.