Inge van Gaal - Rijpert
Within Regulatory Affairs I have many years of experience in creating and submitting (electronic) dossiers.
For pharmaceutical companies I have built the files for many products in eCTD and NEES format, whether or not in a project context, for submissions to the EMA (CP, MRP / DCP, NP), SwissMedic and FDA (NDA).
Within Medical Devices I have experience with building technical files (Technical Documentation) in STED format (Summary of Technical Documentation) and submitting files to a Notified Body. I am also familiar with the format ‘non-In Vitro Diagnostic Device Market Authorization Table of Contents’ (nIVD MA ToC) and I am following its further developments closely.
I am looking forward to working with the passionate Starodub team that has a great diversity of RA knowledge. This collaboration enables me to achieve the agreed goals within agreed timelines.