Registration Affairs

Registration Affairs

Registration Affairs


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.

Our service:

111.png   FDA registration application consult/service

111.png   Early clinical trial in the US

111.png   Domestic registration/application consult

  1)Development strategies consult

  1111.png   Background analysis report

  1111.png   Product analysis report

  1111.png   Targeted product positioning

  2)Registrations apply service

  1111.png   IND information evaluation

  1111.png   IND information writing

  1111.png   IND application

  3)CMC consultation