DMF Letter of Authorization Request Form

Please complete this form to request a Letter of Authorization for our Sartorius CellGenix Drug Master Files. Please bear in mind that our DMFs are submitted to the US FDA CBER center.

Sartorius CellGenix Product

Authorized Party
(i.e. company or individual who submits an application to the FDA - adresses of the LOA

(to whom change notifications should be addressed, as required by 21CFR 314.420(c))

Application Information