PV Alliance

In today’s global pharmaceutical landscape, pharmacovigilance is not only about compliance but also about creating strong and transparent partnerships. At MedWatch Consulting, we support companies in building and managing PV alliances that align with regulatory requirements and business objectives.

Our expertise covers licensing in/out of products, acquisitions, co-development agreements, and distributor partnerships in new markets. We help draft and negotiate Pharmacovigilance Agreements (PVAs), Safety Data Exchange Agreements (SDEAs), and Key Performance Indicators (KPIs) that ensure accountability and trust between all stakeholders.

Whether entering new markets, forming joint ventures, or expanding your product portfolio, we provide the insight and structure to make your partnerships both compliant and commercially successful. With our support, you can focus on growth while ensuring patient safety and regulatory integrity remain at the core.

PV support with licensing in/out of products

PV support with licensing in/out of products

We provide PV support for licensing deals, ensuring clear safety agreements and full compliance.

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Acquisition of products or companies

Acquisition of products or companies

We support PV due diligence and integration during product and company acquisitions.

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Co-development agreements

Co-development agreements

We help define PV responsibilities and agreements in co-development partnerships.

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Distributors, agents, and commercial partners in new markets

Distributors, agents, and commercial partners in new markets

We align distributors and partners in new markets with global PV compliance standards.

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Mergers and joint ventures

Mergers and joint ventures

We support PV integration and compliance during mergers and joint ventures.

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Development of PV agreements, safety data exchange agreements

Development of PV agreements, safety data exchange agreements

We draft and manage PVAs and SDEAs that ensure clear safety responsibilities and compliance.

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KPI development and monitoring

KPI development and monitoring

We design and track KPIs that measure compliance, quality, and efficiency in PV systems.

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System Implementation

System Implementation

Establishing and maintaining compliant pharmacovigilance and medical information systems.

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Inspection Readiness

Inspection Readiness

Preparing for regulatory inspections and PV audits.

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Safety Operations

Safety Operations

Managing case processing, risk management, and reporting.

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Early Access Programs

Early Access Programs

Supporting the implementation of expanded access to treatments.

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