这是一个空菜单
IVD US Regulatory Consulting and Services
- 510(k)
- Clinical Laboratory Improvement Amendments (CLIA) Waiver
- De novo submission
- Emergency Use Authorization (EUA)
- Investigational Device Exemption (IDE)
- Premarket Approval (PMA)
Product Validation Services
- Skilled and experienced experts/ professionals
- Professional/on-time data recording and reporting
- Flexible meeting time and language (English and Chinese)
- Immunoassay and molecular diagnostic
- Experience across various disease areas (heart disease, infectious diseases, oncology, autoimmune diseases, etc.)
- A variety of technologies and platforms (ELISA/CLIA, Point of Care, Micro-array, Multiplex, Lateral flow, etc.)
- Assay development services (also pre-feasibility, design & verification)
- Validation protocols development based on CLSI guidelines and FDA regulations
- Performing technical validation and stability studies of the assay
- Assay analytical performance (detection limit, range, cross-reaction, interferences, etc.)
IVD Clinical Research, Biostatistics and Data Management Services
- Study design and protocol development
- Site selection/qualification
- Site start-up and training
- Monitoring
- Kit management
- Site close-out visits
- Sample and specimen collection
- Central lab management
- Clinical and biostatistical interaction with regulatory agencies
- Database development and EDC management
- Data review and management
- Statistical data analysis and reporting
- Trial master file set-up and maintenance
Central Laboratory Services
- Lyophilization (Sphere) development and service
- Biomarker testing
- SARS-CoV-2 PCR test and serological antibody test
- FDA approved Immunoassays (Cardiac biomarkers)
- FDA approved RT-PCR system
- Automatic RNA/DNA extraction system (Magnetic beads)
- Implementing FDA-cleared assays as needed