EN PL

Pre-authorisation

Before initiation of registration procedure we offer the following services:

  • Documentation assessment in view of registration procedure readiness
  • Assessment of project potential (link to Project assessment and commercialisation),
  • Project management (link to Project organisation and management)
  • Giving opinions on the possibility of registration of the medicinal product, together with choosing the procedure / application type
  • Planning, organisation and active participation in Scientific Advice i pre-submission meeting
  • Preparation/compilation of registration dossier (modules 1-5) for national and European procedures in CTD/eCTD/NeeS format
  • Support in verification of medicinal product invented name for compliance with national and European requirements,
  • Active communication with national Competent Authorities as well as with EMA,
  • Verification of package leaflet and mock-ups/specimens for compliance with national requirements,
  • Documentation conversion into eCTD/NeeS format,
  • Preparation of summary of product characteristic, product information leaflet, mock‑ups/specimen based on QRD templates,
  • Preparation and conduction of Readability tests (protocols, questionnaires and reports from PIL readability testing, bridging reports),
  • Proof reading of mock-ups in line with national requirements,
  • Polish/English and English/Polish documentation translations for the purpose of registration/post-authorisation procedures.