PV Support with Licensing In/Out of Products

Licensing agreements require robust pharmacovigilance (PV) support to ensure that all safety obligations are clearly defined and effectively managed. At MedWatch Consulting, we provide end-to-end PV support for licensing in and licensing out of products, safeguarding compliance while enabling smooth business transactions.

Our services include the preparation and negotiation of Pharmacovigilance Agreements (PVAs), alignment of Safety Data Exchange Agreements (SDEAs), and establishing clear safety responsibilities between partners. We help ensure that safety data flows seamlessly and that both parties meet their regulatory requirements.

By combining regulatory expertise with business insight, we make licensing deals more efficient, transparent, and reliable — supporting both compliance and long-term commercial success.

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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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