A market approval is required for every overseas pharmaceutical enterprise to sell its product in China. However, preparing the registration dossier in accordance with format and content requirements of China CDE can be difficult and time-consuming. ACCESTRA will help you take the pressure off. Our pharmaceutical experts can carry out partial or complete dossier writing on your behalf, while our linguistic experts can translate your dossier into English and Chinese with high accuracy. We deliver only high-quality dossiers, i.e. accurate, compliant and well-integrated. We are informed with the most recent dossier requirements of China CDE and prepare your dossier in paper or eCTD format.
Dossier submission at CDE always has a tight timeline, and therefore hitting the defined timeline is the key of success in obtaining the ultimate market approval. ACCESTRA is aware of the timeline and always submit filing dossiers before the deadline. For NDA or ANDA applications, we start early to take extra time and care in dossier preparation. For us, extended preparation means high quality of dossier but no delay in submission. We understand dossier requirements comprehensively and are in close contact with every Chinese regulatory agency for product registration. Therefore, we can act as your Chinese agent for product registration.