Medical and Regulatory Affairs
Our broad expertise comprises all areas of gaining EU product registrations (Centralised Procedure, MRP, DCP and National Registration). We support you in defining the regulatory strategy for EU and US marketing authorisations. We prepare the required documents on quality, safety and efficacy in the Common Technical Document (CTD) format for your registration dossier. If requested, we also convert the CTD into eCTD format for you.
Securing and maintaining a marketing authorisation throughout all stages of your product’s life cycle is a challenging task. We offer strategic help for navigating regulatory pathways and consultancy in all questions regarding drug development and maintenance.