In accordance with the relevant requirements of the Drug Administration Law of the People's Republic of China, Cell Valley provides comprehensive drug application assistance services and assists in obtaining drug registration certificates. It can provide reliable registration consultation, data review, on-site verification and consulting services for the registration of pharmaceutical products in the domestic NMPA, and help customers obtain the drug registration certificate or drug approval number.
The specific contents include assisting the applicant to prepare the electronic application materials (including the letter of commitment) in accordance with the current regulations, the technical requirements of the electronic disc of the application materials and the electronic file structure of the drug registration application. Assist in receiving and accepting electronic declaration materials. If the application materials are incomplete or do not conform to the legal form and need to be supplemented or corrected, or do not conform to the requirements and need to be rejected, provide consulting, verification and consulting services.
Cell Valley has reached strategic cooperation with inspection and regulatory institutions such as Shenzhen Institute for Drug Control and Research, Drug Administration and so on. It can provide enterprises with CDE-approved quality testing and related reports of cell gene therapy products and important raw materials for cell gene therapy, and provide comprehensive drug application support services.
Shenzhen Cell Valley Biopharmaceutical Co., Ltd. is a comprehensive one-stop outsourcing service provider in China focused on the cell and gene therapy industry. It is also one of the first CRO/CDMO companies in the country to possess GMP industrial production capabilities for clinical-grade retroviral vectors . The company is a major public technical service platform construction project for CRO/CDMO in Shenzhen and is included among the city's latest announced "20+8" strategic emerging industry projects.Shenzhen Cell Valley has the capability for standardized and industrialized production of GMP-grade cell products such as CAR-T cells. Its primary production lines include those for various cell products like CAR-T, CAR-NK, CAR-M, γδT, TIL, and TCR-T. Additionally, the company operates production lines for various viral vectors, including RVV, LVV, non-viral vectors, and AAV, as well as for cellular raw materials used in producing therapeutics such as exosomes, genetically engineered antibodies, cytokines, oncolytic viruses, and vaccines.
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