Your partner in patient safety

“Our team of PV experts partner with the world’s leading Life Sciences companies and regulatory agencies to establish global strategy and run operations to improve patient outcomes. In an era when public confidence in the pharmaceutical sector needs boosting, safety is at the top of Europe’s legislative agenda. Kinapse is uniquely positioned through our long term partnership with the European Medicines Agency and with extensive experience with US, Canadian, Japanese and EU Regulators to implement global PV requirements and support enhanced public health.”
Stuart Donald, Global Head of Kinapse and Board Director

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Our Safety services

We share our clients’ commitment to achieving successful patient outcomes whilst ensuring patient safety. Our market leading integrated services support all your pre and post approval activities.

Safety Strategy

We support clients with a complete set of Safety Strategy services. Whether that means helping clients establish a global PV system, sourcing safety expertise, ensuring standard global SOPs, or solving any other challenge your organisation faces. Each company has its own set of unique challenges – we recognise this and offer tailored solutions to meet your needs.

PV Reports

With a team of over 190 PV experts we produce high quality and compliant safety reports, including PBRERs, PSURs, DSURs, RMPs and Safety Evaluation Reports to name but a few.

Discover how our services can help you

The regulatory burden on pharmaceutical companies is growing continuously. Your clinical, regulatory and pharmacovigilance teams have to work harder than ever to stay on top of requirements and execute more and more routine activities.

Outsourcing your clinical trial transparency and post-approval regulatory/pharmacovigilance support to Kinapse gives you confidence that you will remain compliant in these areas and frees up your teams to focus on more strategic activities.

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Our Insights

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