CRO Services
Analytical, central-lab, and clinical trial services that carry IVD companies through FDA clearance.
Key services
Analytical Study Testing
Product validation and analytical performance testing behind FDA EUA and 510(k) applications.
- Regulatory strategy and submission support
- Risk evaluation
- Product adjustment and performance optimization
- Market comparison and customized reports for global, non-U.S. sale
- Product validation
- Full or customized clinical trial support — study management, biostatistics and data management
- IRB submission, site selection, site monitoring and safety, subject recruitment
- Medical and regulatory writing
- QMS development and compliance
Central Laboratory
Zepto's own high-complexity CLIA lab, run as a central reference laboratory for partner companies.
- Trained professional laboratory staff
- Quick turnaround and data reporting
- Customized client reports
- Post-authorization quality monitoring plan and testing
- Lab Developed Test (LDT) capabilities
- On-site high-complexity CLIA-certified laboratory, high-throughput capable
- BSL 2+ certified testing laboratory
- NIH ITAP-qualified, NIH RADx-approved testing vendor
- Named instruments: Cepheid Xpert Xpress, QuantStudio 5 Dx, BioRad CFX 96
Why Zepto
Proven FDA track record
A history of successful EUA and 510(k) submissions, as an NIH ITAP-qualified and NIH RADx-approved testing vendor.
In-house CLIA laboratory
The same high-complexity CLIA-certified lab that runs FungiFlex® powers fast turnaround and data reporting for CRO clients.
Depth of experience
35+ professionals bringing more than 90 combined years of in-vitro diagnostics experience to every engagement.
Multidisciplinary team
Scientists alongside mechanical, electrical, and software engineers and regulatory professionals, working as one team.
Bilingual scientific service
English and Mandarin Chinese language support for scientific writing, translation, and client communication.
Personalized to your target market
Product-specific clinical study design tailored to each client's regulatory pathway and target market.
Trusted by
A selection of the companies we’ve worked with — not a complete list.
Get started
Scope your project with our team.
Tell us about your device, target market, and regulatory pathway, and we'll follow up with a tailored plan.