Zesheng Tech's professional and experienced regulatory affairs team provides customers with individualized, systematic and all-around registration and filing services, including:
(1)Registration of domestic made formulation products
(2)Registration of imported formulation products
(3)Registration of domestic made API products
(4)Registration of imported API products
Content of Services
(1)Registration feasibility analysis and risk evalsuation
(2)Preparation of clinical trial dossier
(3)Preparation and submission of marketing authorization dossier, FDF and API
(4)Following up on registration review, communications with review officials during registration and answering review questions from officials
(5)Submission of registration samples, following up the registration sample testing
(6)Fulfilling of deficiencies