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 Bio-pharmaceutical Co., Ltd. is a one-stop comprehensive outsourcing service providerfocusing on the cell and gene therapy industry in China, and also the only CRO / CDMO company with the industrial production of clinical grade retroviral carrier GMP. Shenzhen Cell Valley with standardized, industrialized production capabilities.It mainly includes production lines for CAR-T, CAR-NK, CAR-M, mesenchymal stem cells, and astrocytes, as well as several cell raw material production lines, including genetically engineered antibodies, cytokines, exosomes, and viral vectors.Which including retroviral vectors, lentiviral vectors, adenoviral vectors, and adeno-associated viral vectors, and also provides IIT and IND application support services.
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