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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When two or more companies join forces to co-develop a product, it is essential to establish clear pharmacovigilance (PV) responsibilities from the very beginning. At MedWatch Consulting, we provide expert support in drafting and implementing co-development agreements that align safety obligations with regulatory standards.
We help define roles, responsibilities, and data exchange processes between partners, ensuring smooth collaboration and full compliance with FDA, EMA, and ICH guidelines. Our team also supports the creation of Safety Data Exchange Agreements (SDEAs) and customized workflows to facilitate efficient safety communication.
With our guidance, co-development partnerships gain the structure and confidence needed to ensure patient safety, regulatory compliance, and long-term commercial success.
We provide PV support for licensing deals, ensuring clear safety agreements and full compliance.
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We support PV due diligence and integration during product and company acquisitions.
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We align distributors and partners in new markets with global PV compliance standards.
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We support PV integration and compliance during mergers and joint ventures.
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We draft and manage PVAs and SDEAs that ensure clear safety responsibilities and compliance.
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We design and track KPIs that measure compliance, quality, and efficiency in PV systems.
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