I. Service content:
Shenzhen Cell Valleyprovides comprehensive drug application support services in accordance with the requirements of the "Drug Administration Law of the People's Republic of China," assisting in obtaining drug registration certificates. It offers reliable registration consultation, document review, on-site inspection, and advisory services for pharmaceutical products registered with the National Medical Products Administration (NMPA) in China, helping clients obtain drug registration certificates or drug approval numbers.Specific services include assisting applicants in preparing electronic application materials (including commitment letters) in accordance with current regulations, the technical requirements for electronic CD-ROM application materials, and the electronic document structure of drug registration applications. It also assists in receiving and accepting electronic application materials and provides consultation, verification, and advisory services for incomplete or non-compliant applications.Shenzhen Cell Valleyhas established strategic partnerships with inspection and regulatory agencies such as the Shenzhen Institute for Drug Control and the Greater Bay Area Branch of the National Medical Products Administration, providing companies with CDE-approved quality testing and related reports for cell gene therapy products and key raw materials for cell gene therapy, and offering comprehensive drug application support services.
II. Service Cases
Shenzhen Cell Valley and Fosun Kite have launched a close collaboration on the IND application for new pipelines and have joined forces in talent training and early-stage research and development to jointly enhance the competitiveness of the upstream and downstream industrial chain based on retroviruses and help verify, translate, promote and apply scientific research results in the field of cell therapy.
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