Regulatory affairs medicinal products consulting services drug registration medicines Poland

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 authorizations including

● variations

● renewals

● notifications

● pharmacovigilance

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