Service platform
Service Platform
Service platform
Service Platform
Related services and solutions
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Registration and regulatory services
Registration filing and regulatory services
Jiuzhou Pharmaceutical has a drug administration affairs team with global registration and application experience, which is committed to providing domestic and foreign customers with regulatory support, registration strategy planning and registration project management, bilingual declaration document writing, registration verification, defect response, post-market change management and submission of application materials and other product life cycle drug administration solutions。
The core members of the registration team have more than 10 years of experience in drug registration and rich project management experience，Start with drug project research，To drug research and development, technology transfer, process verification and other whole process tracking，Ensure that internal data comply with regulatory requirements of various regulatory bodies，At the same time familiar with the official channels of communication with various pharmaceutical administration departments，Good grasp of the review requirements，Accelerate drug market。
- CMC
- Product development plan and application strategy evaluation
- Official communication.
- Regulation interpretation
- Analysis of gaps between internal data and regulatory requirements
- One-on-one consultation
- Register related whole process project management
- IND, NDA and ANDA Pharmaceutical application documents are written in both languages
- Assist clients in communicating with regulatory authorities
- Monitor and follow up the progress of the review
- Defect reply data writing
- Annual report and supplementary application documents are written in both languages
- Verification of data preparation
- Assist in site verification and flight inspection
Business cooperation
Innovative drug CDMO service
