Amarin Technologies S.A. has research and development capabilities, which allow the Company to perform and control all aspects of the product development process. An experienced team coordinates and manages all of the Company's research, project planning and product development programmes. The Company performs an exhaustive analysis of the background of the selected agent for a transdermal formulation before beginning the pharmaceutical development, including the evaluation of the patent status. In this field, online services are regularly consulted by specialised personnel of the Company.
Amarin possesses modern formulation and analytical laboratories, which work following GMP and cGLP guidelines. The Non-Hormonal Plant where the fentanyl patches are manufactured received EU GMP approval in 2006.
The pre-clinical studies (e.g. primary irritation, sensitisation, and pharmacokinetics in animals) are carried out following cGLP guidelines, in third-party facilities.
Amarin also performs clinical studies by means of properly designed protocols in order to evaluate safety, pharmacokinetics and efficacy of the products under development. Clinical trials are performed according to cGCP directives and local regulations in hospitals and other health centres. All studies are closely supervised by certified clinical monitors and physicians, following quality policies and SOPs.