Technical Service
Service Introduction
Drug registration service
We provide services for drug registration, regulatory and process consulting, IND applications for innovative drugs, NDA submissions for new drug approvals, and preparation and submission of supplementary application documents, supporting pharmaceutical R&D and manufacturing companies in obtaining regulatory approvals.
Inquiry
Service Advantages
The registration team has more than 10 years of consulting experience in the pharmaceutical industry, rich experience in registration application and document writing, and is familiar with the latest domestic and international laws and regulations in the pharmaceutical field. It brings together many industry experts and has built a service system for all core links in the entire life cycle of drugs.
Service Type
Domestic registration
Service Content
| Serial number | Service Content | Deliverables |
| 01 | Pre-registration consultation for drugs and formulation of registration strategies | |
| 02 | CDE communication meeting application, material preparation and meeting guidance. | |
| 03 | Writing, translation, review and submission of the complete set of CTD materials | |
| 04 | Track and manage the entire official review process, assist with on-site inspections and standard review inspections, and receive additional questions and answers from CDE. |
Project Process
Confirm customer needs and formulate drug registration strategies; write and submit drug registration application materials; track and manage the drug review process; and provide regulatory support after approval.
Case/Data Display
Clinical trial approval for Class 1 new biological products
Notice of Clinical Trial of Category 1 New
