Medicinal products

We provide a comprehensive service starting from Customer’s portfolio analysis, presentation of product development proposals, selection of a registration strategy, development of a medicinal product, in accordance with current legal requirements and ICH guidelines, preparation of complete registration documentation in CTD / eCTD format and lead a process of registration of a medicinal product in a national procedure or European procedures to obtain a marketing authorization for a medicinal product.

Additionally, we provide service in the field of audit dossier, in compliance with current legal requirements as well as activities enabling the transfer of a medicinal product to a new manufacturing site of a medicinal product.