Regulatory Affairs

Probio RA team provides professional CMC regulatory support for the whole lifecycle of biological products. We participate in creating development plan, conducting risk assessment, writing application dossier, support the communicating during the official review for various development projects of biological products. We also provides regulatory and strategic suggestions for those issues that may encountered in the development, which make it much easier for the promotion and delivery of your projects.

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.