Regulatory Affairs
Led by expertise, we provide strategy and submission service across drug full life cycle.

The project is promoted in an orderly and compliant manner through the close cooperation between team members, who are rich in project design and implementation experience.

Service Scope

Pre-Clinical

Pre-IND meeting
IND submission

Clinical trial phase I~III

CT startup submission
Amendment during CT
Pre-NDA meeting
NDA submission

Post marketing

Post market amendment and maintain

Others

Strategy consultation on
drug application and R&D
Compliance consultation on drug clinical trials, manufacturing and distribution.
Service Advantages
Rich Experience and Customized Strategy
  • Rich experience of drug registration, ensure the R&D plan reasonable and project execution in compliance of regulatory requirement.
  • Personalized submission strategy and plan based on client request and R&D status.
Close Team Work and Compliance First
  • Work with clinical operation team closely to complete clinical trial startup submissions within study timeline.
  • Suggest and resolve compliance issue during clinical trial execution.