We have practical experience in local law, knowledge of additional rules and requirements, EU guidelines interpretation and knowledge of the way how local Authorities really work which assures efficient services. We know the reality.
Considerable professional experience and constant monitoring of changes of legal requirements allow us to provide high quality consulting services and ensure a comprehensive approach.
Besides regular regulatory services we can help you with scientific dossier preparation, liaison with authorities, preparation of responses to the formal and scientific List of Questions/Deficiencies.
Our regulatory affairs and consulting offer is comprehensive, offering consultancy and full scope of support for the registration, renewal of medicines and variations.
- marketing authorization of medicinal products in Poland and in Europe
- national and EU proceedings(MRP, DCP)
- maintenance of MA including variations, renewals, notifications
- Preparation of eCTD and NeeS
- PIL readability testing/PIL user testing
- translation of Summary of Product Characteristic (SmPC), Patient Information Leaflet (PIL), labelling including Braille
- other types of regulatory tasks