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
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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
Central Laboratory

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


  • 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

  • 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

Contact Zepto Life Technology

Contact Information

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How can we help you?

Send us a message.