is quite different from EU or US procedures. Before 2010 dossier variations were relatively simple procedure.
Currently Russian regulatory requirements for variations propose different types of variations, some of them can require quality control expertise, local clinical study or even both.
Our team has experience since 1999 in registration of pharmaceutical variations namely:
We provide full cycle service of timely registration of all kinds of pharmaceutical variations as well as consultation on optimal strategy of registration of a particular variation - whether it requires immediate registration in Russia or can be postponed and cumulated with upcoming dossier variations. MoH approval of some types of variations is not obligatory.