Is your organisation aiming at a scientific advice with authorities – and in need of professional assistance? Our team of regulatory and medical specialists can help you prepare the documents and accompany you at the meeting.
Our medical specialists provides preparation of (e)CTAs and eINDs including EC-application preparation, ODDs, PIPs, and RMPs, in addition to pharmacovigilance and DSUR/PSUR services. Furthermore we do ATC code applications.
For more information about our medical affairs services, please contact our R&M Development Team.