Our company constitutes 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) and were involved in preparation of Polish pharmaceutical regulations.
If you are interested in marketing authorization of medicinal products, medical devices, food supplements and cosmetics in Poland and in EU please visit our website: www.toppharm.pl, www.regulatory-service.pl, www.regulatory-affairs.plE-mail:
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We have practical experience in local law, knowledge of additional rules and requirements, EU guidelines interpretation and knowledge of the way how Polish Authorities really work which assures efficient regulatory affairs in Poland. 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 services for medicinal products:
► marketing authorization of medicinal products in Poland and in Europe
● national procedure
● European procedures (MRP, DCP)
► maintenance of marketing authorization (variations, renewals, notifications, pharmacovigilance)
► parallel import authorization
► PIL readability testing/PIL user testing according to EU guidelines and requirements including bridging studies to reduce cost of testing group of products
► preparation and translation of Summary of Product Characteristic (SmPC), Patient Information Leaflet (PIL), labelling including Braille
► any other regulatory affairs issues - we are open to all inquires.
Besides regulatory affairs services for medicinal products, medical devices, food supplements and cosmetics we offer you broad range of pharmaceutical consulting services:
► preparation of the dossier and scientific review of the dossier in relation to planned marketing authorization, type of application (product category), studies in possession of the client and any foreseen problems/questions from the Authority together with solutions to prevent our client from most difficult questions resulting in significant costs increase and huge delays
► preparation of expert reports, Quality Overall Summary etc.
► preparation and translation of Summary of Product Characteristic, Patient Information Leaflet, labelling including Braille according to current EU and Polish Authority requirements
► preparation of responses to formal and scientific List of Questions/Deficiencies from the Authority (we have practical experience, we assessed dossiers and prepared lists of questions for years)
► investigation whether product can be authorized as food supplement in Poland.
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