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Regulatory affairs services in Poland (medicinal products, medical devices, food supplements, cosmetics, pharmaceutical consulting).
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.
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 (see Consulting) - 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. Read more
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.
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 (see Consulting) - 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. Read more
Other Products
- Medical Product Consulting