Profound knowledge of ICH and the regulation of Chinese regulatory authority. Attention and interpretation to changes of regulation and technical guidelines of CDE, CDR and relevant inspection departments. Precise understanding of registration application essence and concrete requirements of application. Provides one-stop service of reasonable registration strategy consult, setup medicinal product registration plan.
Stable connection with the regulatory department and profound experience in preparing and organizing CDE communication meeting, and final registration information delivered to CDE for approval.
FDA registration application consult/service
Early clinical trial in the US
Domestic registration/application consult
1）Development strategies consult
Background analysis report
Product analysis report
Targeted product positioning
2）Registrations apply service
IND information evaluation
IND information writing