Interim Swiss Marketing Authorization Holder and Longstanding Responsible Person Support for a Multinational Biotechnology Company
A global biotechnology company that develops therapies to treat a range of rare diseases asked SFL to file a Marketing Authorization Application on their behalf and act as Marketing Authorization Holder (MAH) in Switzerland until the company founded their own Swiss entity.
SFL managed to obtain the Marketing Authorization on behalf of the client and acted as MAH for several years, including for product launch. Once the company founded their own entity in Switzerland, key SFL personnel were asked to remain in their positions as Swiss Responsible Person (RP) and Deputy RP on a mandate basis, ensuring oversight of the company`s activities (batch releases, QMS maintenance etc.), and as Responsible Person for Pharmacovigilance (PVRP) and Deputy, ensuring maintenance of a compliant PV system.