API/Generic Submissions
1.API: Prepare and submit DMF/EDMF/CEP application dossiers to FDA/EDQM/EU nations.
2.Generics:
(1)Prepare and submit ANDA dossiers to FDA;
(2)Prepare and submit application dossiers to EMEA via centralized route or EU nations via decentralized route
(3)Prepare and submit WHO Prequalification dossiers