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.”
Aileen Fisher – Head of Regulatory Affairs & Pharmacovigilance
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.
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.
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.