Registration and pharmacovigilance

Marketing Authorization of a medicinal product is a permission to place a medicinal product on the market and its listing into the registry of registered medicinal products. It is a basic prerequisite for introduction a medicinal product on the pharmaceutical market in the Slovak Republic. Thorough knowledge of the processes, legislation and necessary documentation is required for the swift and successful registration procedure of a medicinal product. Equally important is the maintenance of the life cycle of the registered medicinal product i.e. properties of the medicinal product in accordance with the registration dossier after its placing on the market.

Based on many years of experience and knowledge of these processes we provide the professional services and expert advice in the area of the registration of medicinal products, notification of medical devices and food supplements.

We are the members of the Slovak Association of Regulatory Affairs Professionals SARAP.