Authorisation procedure
We are happy to assist you in the implementation of the authorisation procedure (centralised und noncentralised).
Centralised procedures (CP) enable the authorisation of a pharmaceutical in the entire European Economic Area.
Noncentralised (decentralised (DCP), mutual recognition (MRP) and national) procedures are used to obtain national authorisation in one or more countries
- Data management and statistical analysis
- Medical Documentation in context of clinical trials or authorisation procedures of pharmaceuticals in compliance of the CP, MRP und DCP procedures (Common Technical Document (CTD))
- Creation of dossiers for the benefit assessment by the German Federal Joint Committee (G-BA), HTA (Health Technology Assessment)