Extensions

Variation or new marketing authorisation?

A question we are frequently asked.
We check the regulatory requirements for your line extension and the eligibility of the corresponding basic marketing authorisation. This is particularly beneficial to you when developing products for several target markets.

Personal and competent

Our experts prepare the content and form of your documentation and guide you through the procedure with all the relevant authorities and/or the EMA. If required, several marketing authorisation procedures can be conducted simultaneously. Your personal contact from our Lifecycle Management team supports you from the initial idea right through to successful marketing authorisation.