Inge Groenewoud

Coming from the generic business, I have many years of experience in working in the pharmaceutical industry for human medicines. Within Regulatory Affairs I have worked with European submissions via centralised and decentralised procedures, and on regular returning occurrence also with mutual recognition procedures.

My tasks varied from preparing, composing and submitting initial MA applications to post approval applications such as variations, renewals and notifications. Preparing, composing and submitting the responses for the aforementioned applications was also part of my responsibilities. 

All of the above was mostly applicable to Module 1, but I also know how to find my way in the other Modules of the dossier. This knowledge is also very useful when I am formatting CTD section documents, so that they can be made submission ready.

I enjoy being a part of the enthousiastic STARoDub team and to be able to contribute to our customers’ results and successes.