Regulatory Affairs

Pharma Services Switzerland

Since the founding of MARAS, Regulatory Affairs has been one of the largest and most important areas in which we specialise. For the authorisation of medicinal products for the Swiss market, we offer you strategic advice and a comprehensive range of services that cover the entire lifecycle of your products:

New submission of marketing authorization application (NAS, KAS)
Maintenance of marketing authorization (variations, renewal)
Preparation of documentation modules 1–5 of the registration dossier
Adaption of EU dossiers to specific requirements in Switzerland (Swissmedic)
Evaluation of marketing authorization documents
Advice on the development of marketing authorization strategies
Creation of eCTD sequences (software eCTDmanager) and electronic dossiers in eDok format
Control and maintenance of medicinal product information and packaging materials
Taking over the function of marketing authorization holder for companies not having a pharmaceutical operating license in Switzerland
Training of new employees