Regulatory consulting dossier preparation regulatory affairs Poland

Pharmaceutical consulting Poland

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

► in-licensing and out-licensing of dossiers (sourcing of dossiers for portfolio), dossier auditing and revision

► preparation of eCTD and NeeS and dossier publishing including consultancy on country specific requirements

► 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

PIL readability testing/PIL user testing according to EU guidelines and requirements including bridging studies to reduce cost of testing group of products

► 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 and EU.

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