About Us » Regulatory Affairs

Regulatory support:

Conduct risk assessment based on the application requirements and the specific characteristics of each project and each product. Participate in creating of development plans.

Provide regulatory support, answer the regulatory questions in a timely manner and provide suggestions on application strategy for the project team.

Provide process change assessment and application strategy advices.

Provide CMC advices on non-clinical and clinical study.

Application service:

Provide CTD writing (CMC and non-clinical modules) service in accordance with international common standards, such as ICH guidelines.

Respond to RFI from regulatory agencies in a timely manner, interpret the comments in the approval letter and support on the drafting of the action plan.

By collaboration with third-party CRO, we also provide clinical and registration agent services.