Archemin

Advice & reporting for the chemical and pharmaceutical industries

e-submissions Belgium

Tue, 30/08/2011 - 4:39pm -- Ludwig Everaert

As from 1 September 2011 on, a validation report must be joined to all electronic registration applications submitted to the Belgian authority (FAMHP).

The e-CTD validation report must be generated using the most recent version of the Extedo or Lorenz validator. Our Regulatory Affairs professsionals have used the Extedo software since early 2005 and therefore the submissions we make on behalf of our clients will remain fully compliant.