We are specialists in the preparation and execution of submission procedures in Europe (national, CP, MRP, DCP) and worldwide (LatAm, MENA & APAC). We ensure adherence to local and international regulatory requirements.
Additionally, we provide support in reformatting dossiers into "state of the art standards" like eCTD, ASEAN etc. and in the creation and maintenance of PILs and SPCs to meet regulatory standards.