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Registration, Filing and Regulatory Support
Jiuzhou Pharma's regulatory affairs team has extensive experience in global drug registration and filing. We are committed to providing domestic and international customers with regulatory affairs solutions throughout the product lifecycle, including regulatory support, registration strategy planning and registration project management, bilingual application dossier preparation, registration inspection, deficiency letter responses, post-approval change management, and submission of applications.
The core members of our registration team have over 10 years of drug registration experience and project management expertise. We closely track projects throughout the product lifecycle, from feasibility research to drug R&D, technology transfer, process validation and beyond, to ensure that internal documents meet the requirements of regulatory agencies. Our efficient communication with regulatory agencies and in-depth understanding of review criteria help accelerate the time to market for products.
- CMC
- Product development plan and registration strategy assessment
- Communication with authorities
- Regulatory interpretation
- Gap analysis between internal documents and regulatory requirements
- One-on-one consulting
- End-to-end project management for drug registrations
- Preparation of bilingual CMC dossiers for IND, NDA, and ANDA applications
- Facilitation of customer communication with regulatory agencies
- Monitoring and tracking of review progress
- Response to deficiency letters
- Preparation of bilingual annual reports and supplements
-Preparation of materials for inspections
-Support for onsite inspections and unannounced inspections
Business Collaboration
Innovative Drug CDMO Services
Tel: 86-576-85588039
E-mail: bd.cdmo@jiuzhoupharma.com
