About Us
RepoDx Solutions
CDMO、CRO、CMO Solution
01 Mature production quality system
It has passed ISO13485 (TüV) and other domestic and foreign system certification;
It has built and put into operation an area of 2,500 square meters, 2 10,000-level production lines and 1 100,000-level production line, which can achieve an annual production capacity of more than 10 million in vitro diagnostic reagents;
02 Professional clinical registration team
The company's team has completed a number of clinical and registration work for three types of medical devices, and has accumulated rich experience in in vitro diagnostic reagent projects;
03 Whole process service
According to the needs, provide CMO, CDMO, CRO and other diversified services, full-process project management, to help projects with high quality, compliance and rapid transformation;
CDMO
Entrust
Product transformation services, compliance quality management system construction;
Set up sample reagents for commissioned production, sample testing and inspection;
Raw material screening and procurement supplier management;
Warehousing and logistics management, factory inspection and verification
CMO
Production
Production line expansion and production license transfer;
High-volume production management;
Production process and cost optimization;
Capacity/quality/management assurance
CRO
Register
Product market research and data preparation;
Medical device product testing and evaluation;
Medical device clinical trial/evaluation services;
Medical device product registration/filing services;
Medical device quality management system establishment services;
Medical device business license/filing service
车辆展示
Vehicle Display
Contact Us:
Jiangsu RepoDx Biotechnology Co.,Ltd.
Add: 1-2 floors, Building C6, Jianghai Zhihui Park, No. 266, New Century Avenue, Tongzhou District, Nantong City, Jiangsu Province
Shanghai RepoDx Biotechnology Co.,Ltd.
Add: Room 408, Building 4, Juke Biological Park, No. 333 Guiping Road, Xuhui District, Shanghai
REPODX BIO
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