Preparation of product information
The Importance of Product Information in Medicinal Product Pre-Authorisation
Preparation of product information is a crucial step in the pre-authorisation stage of a medicinal product. Product Information (PI) consists of essential documents that provide officially approved and accurate information for healthcare professionals, such as doctors, nurses, and pharmacists, as well as for patients. These documents include critical details such as dosage, contraindications, and potential side effects of the medicine. The core components of the PI are the Summary of Product Characteristics (SmPC), Package Leaflet (PL), and labelling. These documents play a vital role in ensuring patient safety and effective communication of product information.
Comprehensive Product Information Services by SciencePharma
At SciencePharma, we are highly attentive to the requirements outlined in the European guidelines regarding the preparation of the Product Information, as well as the graphic designs for leaflets and packaging (Module 1.3.2 CTD). This includes a focus on both immediate and outer packaging. We may support you also in the preparation of this important part of documentation.
Our services include:
- Preparation of Summary of Product Characteristics (SmPC), Product Leaflet (PL), and immediate & outer labelling. We prepare these documents based on the Quality Review of Documents (QRD) templates.
- Verification of package leaflet and labelling. We thoroughly review the inner and outer labelling mock-ups for compliance with regulatory requirements, ensuring they adhere to both local and European standards.
- Conduction of Readability Tests. We conduct these tests and prepare all necessary documentation, including protocols, questionnaires, and reports, to ensure the leaflets are understandable to patients.
- Writing of Bridging Reports. We develop comprehensive Bridging Reports that justify the rationale for bridging, provided in a format ready for submission.
- Translation Services. We offer professional Polish/English and English/Polish translations of the PI for registration and post-authorisation procedures.
- Educational Materials Verification. We also verify educational materials, including Risk Management Measures (RMM), to ensure compliance and clarity.
Our extensive experience in regulatory affairs and product information preparation allows us to support companies in navigating the complex requirements of medicinal product authorisation.