New Biological Products Application Service Platform

  • Introduction

Bovax project service management team has more than 15 years of experience in R&D and registration of biological products. We are well-versed in the NMPA laws and regulations for biological products registration, and can offer services to both domestic and international clients, including guidance on non-clinical research, policy consultation, and registration application management. Our project application platform is able to provide comprehensive management and create a comprehensive application plan.

*Pre-communication service for project plan.

*Non-clinical research regulatory guidance service.

*Preparation, application, communication and reply service for communication meeting.

*CTD dossier compiling guidance, review and submission service; certification documents templates offering service.

*Whole process following service of CDE technical review; consulting service on response to deficiency letter and replies to experts.

*On-site inspection assistant service and biological products test service.

*Information retrieval service on competitive products registration progress

*R&D communication and consultation service for projects in clinical trials.