POLISH AUTHORITY

Our company consists of people with high practical experience in EU regulatory affairs gained in Polish Authority and consulting companies therefore we are able to help you with smooth marketing authorization of medicinal products, medical devices or food supplements and with all processes related to maintenance of marketing authorization (variations, renewals etc.) as well as with any other regulatory affairs issues in Poland and in Europe... We are former Polish Authority experts who assessed scientific dossier in MRP, DCP and central procedure, we were involved in preparation of Polish pharmaceutical regulations and we know that no training can give you knowledge of rules not described in the law, local interpretation of EU guidelines etc. Only practical experience in local law, knowledge of additional rules and requirements, EU guidelines interpretation and knowledge of the way how local authorities really work assures efficient services. We know the reality.

Primary location: Warsaw