Monday, 30 January 2023

Partner 7: Therakind Ltd (THERAKIND)

Therakind is a private European paediatric pharmaceutical company established in 2006. The company’s primary objective is to increase the availability of authorised paediatric medicines. Therakind has experience in paediatric drug evaluation, formulation, and drug delivery; clinical and regulatory strategy, ensuring an optimal clinical programme whilst avoiding unnecessary paediatric trials; paediatric clinical study design, management, analysis and reporting; interacting with Regulatory Authorities and obtaining scientific advice; securing agreements for Paediatric Investigation Plans (PIPs),and approvals for clinical trial and marketing authorisations. As a SME, Therakind regularly works with third parties, as required, and has extensive experience of successfully managing these contracts. Therakind was pivotal in the process of bringing to market Buccolam®, a treatment for prolonged acute convulsive seizures in children which was granted a European centralised Paediatric Use Marketing Authorisation (PUMA) by the European Commission in September 2011. This is the only PUMA granted. Therakind was responsible for the regulatory development strategy (securing agreement of a PIP) as well as the design, management and sponsoring of the clinical trial.

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This project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no: 602041
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