Compiling documents for MAA

(e.g. M 1.5.1, M 1.5.2, M 1.6, M 2.2, M 2.4, M 2.5, M 2.6, M 2.7, M 4 and M 5)

Periodic Safety Update Reports

(in close cooperation with the MAH and based on data provided by the MAH)

ADD-COs for unlimited MA

(in close cooperation with the MAH and based on data provided by the MAH)

Expert Statements for answering deficiency letters

Update of existing NCOs and COs

Paediatric Investigation Plans

Risk-Management Plans

Clinical Study Reports

 

Of course, the particulars and documents of a dossier may also be processed in part.