RFI

MENU

Szukaj

    RFI

    Drop in a message and we will reach out to you

    Product Information

    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 Product Information & Artworks covering:

    • 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)

    How can we help You?

      Please be advised that the administrator of personal data entered in the above form is SciencePharma Sp. z o.o. with its registered office in Warsaw, Chełmska 30/34. These data are processed in order to receive incoming correspondence and respond to it. Providing personal data is voluntary, but necessary to send the form. Each person has the right to access their data and correct it.

      You can read the details on the protection of personal data here.