Our company consists of people with high practical experience in EU regulatory affairs gained in Polish Authority and consulting companies. We are former Polish Authority experts who assessed dossier in national procedure, MRP, DCP, central procedure (EMEA/EMA) and were involved in preparation of Polish pharmaceutical regulations.
We have practical experience in local law, knowledge of additional rules and requirements, EU guidelines interpretation and knowledge of the way how local Authorities really work which assures efficient services. We know the reality.
Therefore besides common regulatory affairs services for medicinal products, medical devices and food supplements we can help you with scientific dossier preparation, liaison with authorities, preparation of responses to the formal and scientific List of Questions/Deficiencies. We can foresee what will happen which in turn help you plan your activities.
Our regulatory affairs and consulting offer is comprehensive.