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,

  • Environmental Risk Assessment (ERA),

  • Medical writing – preparation of medicinal product registration dossiers,

  • CTD Module 3 - Quality,

• 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),
• Proof reading of mock-ups in line with national requirements,
• Bridging Reports;
• Polish/English and English/Polish documentation translations for the purpose of registration/post-authorisation procedures;
• Medical device regulatory analysis.