Description

A software system which allows Pharmaceutical Companies to design and to electronically submit the Dossier of Medicinal Products to the Agency, in accord with the CTD/eCTD Standards (Common Technical Document/electronic Common Technical Document).

It is an effective and complete solution: in addition to the above, it allows the implementation of the maintenance requirements of the Dossier during its Life Cycle and it can be used for the design of the Drug Master File, which is a requirement in the Pharmaceutical Industry for the production of Active Ingredients, with reference to the components and in accord with the terms defined in the ICH Standards.