Common Technical Doument (CTD / eCTD / NeeS):

- non-clinical and clinical expert reports (module 2.4; 2.5; 2.6; 2.7 of CTD),
- Quality Overall Summary (module 2.3),
- preparation of Environmental Risk Assessment for Medicinal Products (1.6.1 / 1.6.2),
- preparation and translation of Summary of Product Characteristic (SPC), Patient Information Leaflet (PIL), labeling including Braille according to current EU and Polish Authority requirements, professional translations,
- preparation of full registration dossiers in CTD / eCTD / NeeS format (especially for Well Establish Use products) and scientific review of the dossier in relation to planned marketing authorization,
- registration of medicinal products in Poland / EU via MRP, DCP and National Procedure,
-  preparation of scientific advices concerning the scope of requirements for the registration dossier, evaluations on classification of a preparation as a medical device/cosmetic/ food supplement,

More detailed information and other regulatory affairs issues are available upon request.

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