In response to the interests of our clients we constantly modernise our services. We offer you a wide range of services, among others:

REGISTRATION DOSSIER

• Non-clinical and clinical expert report in CTD format
• Overall quality summary and module 3 CTD
• Elaboration of qualitative and quantitative recipes
• Elaboration of analytical methods with validation
• Management of registration procedures on behalf of Marketing Authorisation Holder
• Local Marketing Authorisation Holder representation in the scope of medicinal products registration procedures

INFORMATION LEAFLET

• Preparation of information leaflet set (Summary of Product Characteristic, Patient information leaflet, package labelling) based on current law and QRD requirements
• Periodical updates of information leaflet text.

We have elaborated over 100 information leaflet sets, mainly in accordance with European procedures.

PROFESSIONAL TRANSLATION SERVICES

• We prepare professional translation of registration dossier (quality documentation, non-clinical and clinical reports), articles and scientific reports.