Preparation of product information
Preparation of product information is one of the pre-authorisation stage of a medicinal product. Product Information (PI) are documents providing officially approved information for healthcare professionals (e.g. doctors, nurses) and patients on a medicine (dosage, contraindications, possible side effects and others). The PI includes the Summary of Product Characteristics (SmPC), Package Leaflet (PL) and labelling.
We are mindful about module 1.3.2, under which the applicant presents graphic designs for leaflets and packaging – also in this field SciencePharma can support your company. Therefore, we provide comprehensive services in the field of preparation of product summary & Artworks, which cover:
- Preparation of Summary of Product Characteristic, Product Leaflet, immediate & outer labelling based on QRD templates,
- Verification of package leaflet, inner and outer labelling mock-ups for compliance with national & EU requirements,
- Conduction of Readability tests & preparation of all related documents (protocols, questionnaires and reports),
- Writing of a Bridging Reports containing the rationale for bridging in a ready-submit form ,
- Polish/English and English/Polish Pl translations for the purpose of registration/post-authorisation procedures;
- Educational materials verification (including Risk Management Measures, RMM)