Your partner in patient safety

Kinapse’s Pharmacovigilance service line has been engineered to accommodate the needs of biotech and pharmaceutical companies to meet drug, vaccine and device vigilance obligations. Our team of experts partner with the world’s leading companies and regulatory agencies to establish global strategy and operations in a true collaboration. 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 partnership with the European Medicines Agency and with extensive experience with US, Canadian, Japanese and EU Regulators to implement global PV requirements including the new European legislation and support enhanced public health.

A consistent, highly skilled and committed team with in-depth subject matter expertise which can produce high quality both in the more intellectually demanding activities within PV, as well as the more routine processes are unique with our adoption of industry best practices which we will recommend for our partnership with you. Additionally, the Senior Members of our Pharmacovigilance team have supported industry at a global level in conferences and academic programs in best practices for Quality within Pharmacovigilance, Global PV Legislation, Risk Management Planning, Medical Evaluation of Aggregate Reports and Individual Safety Case Report structuring.

 

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For further information on our services in PV and Drug Safety, please contact us at info@kinapse.com

 

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