Zepto CRO Services
IVD & Medical Devices
Proven Track Record With Customized Support & Consulting
Why Zepto?
- Extensive IVD Development Technology Expertise
- Up-to-Date IVD Knowledge and Regular Implementation
of IVD - Client-Specific Personalized Trial Support
- Proven Track-Record of Successful Submissions
- Professional Bilingual Scientific Service and Translation
About Us
Zepto Life Technology has a proven track record of successful FDA IVD submissions with verification and validation testing as well as IVD clinical trial support. At Zepto, we strive to provide clinical and CRO support that’s customized specifically to each clients’ individual needs and respective target market. Learn more about us on our homepage.
Central Laboratory
Our in-house high complexity CLIA certified central laboratory allows for customizable testing services as well as lab developed test (LDT) capabilities.
- High Complexity CLIA Certified Lab
- Trained Professional Staff
- Quick Turnaround and Data Reporting
- Customized Client Reports
- Post Authorization Quality Monitoring Plan/Testing
- Lab Developed Test (LDT) Capabilities
IVD Performance Testing
Our team of scientists have extensive knowledge in both IVD development as well as IVD submissions. Our expertise in IVDs means that we can offer both product validation as well as product optimization.
- Regulatory Strategy and Submission Support
- Risk Evaluation
- Product Adjustment Support
- Market Comparison & Customized Reports for Global Non-U.S. Sale
- Product Validation
Our IVD Team’s Experience
Immunoassays
- Cardiac Biomarkers
- Autoimmunology
- Cancer Markers
- Small Molecules
- Cytokines
Molecular Technology
- Nucleic Acid Extraction (column/beads based)
- Automated Extraction
- Real-Time qPCR
- Isothermal Amplification
Immunoassay Technology
- ELISA
- Chemiluminescence Immunoassay (CLIA)
- Fluoroimmunoassay (FIA)
- Lateral Flow Detection
- Agglutination Tests
Molecular Biology
- Liquid Biopsy
- Respiratory Pathogens
- Blood Infection Detection
Key Services
- Regulatory Support
- FDA Communication & Regulatory Consulting
- Medical Writing & Operations Expertise
- Central Lab Services & Analytical Performance
- ELISA & Immunoassay Expertise
- Professional Communication in English & Mandarin
- Lab Developed Test (LDT) Capabilities
- Full or Customized Clinical Trial Support
- Study Management
- Biostatistics and Data Management
- Site Selection, Site Monitoring and Safety
- Technical and Regulatory Writing
- QMS Development and Compliance
