Zepto CRO Services
IVD & Medical Devices
Industrial Focus of Zepto CRO
Zepto CRO
Zepto Life Technology’s analytical testing team are ready to contribute to your analytical studies and FDA regulatory submissions, ensuring the success of your projects.
Key Services
Professional Facilities
Team Experience & Expertise
Professional Facilities
Our professional facilities include in-house CLIA certified high complexity laboratory with BSL 2+ certification
Key Services
Regulatory support, FDA communication & regulatory consulting, QMS compliance, and LDT capabilities are just some of our key services.
Team Experience & Expertise
Our team of talented & dedicated scientists have many areas of expertise. Click to find out more.
Molecular Biology
CRO Service Unit Overview
Why Zepto?
Up-to-Date IVD Knowledge
Extensive IVD development technology expertise and regular implementation of IVD
In-House LDT Capabilities
Our in-house high complexity CLIA certified central laboratory allows for internal lab developed tests (LDT)
In-House LDT Capabilities
Our in-house high complexity CLIA certified central laboratory allows for internal lab developed tests (LDT)
Personalized Trial Support
Fully customized clinical trial support for study management, biostatistics & data management, and many more
Personalized Trial Support
Fully customized clinical trial support for study management, biostatistics & data management, and many more
Proven Track-Record
Successful completion of various FDA EUA and 510(k) applications as well as analytical studies and validations
Bilingual Communication
Professional bilingual communication in both English & Mandarin for scientific services and translations
Key Services
Our CRO unit specializes in analytical study testing for a wide variety of product types as well as our in-house high complexity CLIA certified central reference lab testing.
Analytical Study 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
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
Professional Facilities
Our comprehensive suite of services includes regulatory support and FDA communication and consulting, leveraging extensive expertise in medical writing and operations. We excel in central lab services, analytical performance, and possess molecular diagnostics, point-of-care testing, over-the-counter testing, rapid lateral flow test, and immunoassay expertise. Our team is proficient in professional communication in both English and Mandarin, providing a unique advantage. We offer Lab Developed Test (LDT) capabilities and flexible options for full or customized clinical trial support, encompassing study management, biostatistics, and data management. Additionally, our services extend to site selection, site monitoring, safety, technical and regulatory writing, as well as Quality Management System (QMS) development and compliance.
Key Notes
Zepto Life Technology is a provider of analytical studies with a proven track record in supporting FDA Emergency Use Authorization (EUA) and 510(k) applications.
Our company specializes in conducting high-quality analytical studies, ensuring accuracy and reliability in regulatory submissions.
Zepto’s CRO services come with robust capability to design & execute studies based on client need, including environmental control, stability, shelf life, & many more. Reach out today!
Zepto’s CRO team is ready and equipped to support your product submissions every step of the way. Our experiences include FDA Emergency Use Authorization (EUA) & 510(k) submissions as well as submissions for countries outside of the United States.
Our facilities includes an onsite high-complexity CLIA laboratory and testing laboratory as well as a BSL 2+ certified testing laboratory.
Zepto Life Technology is a provider of analytical studies with a proven track record in supporting FDA Emergency Use Authorization (EUA) and 510(k) applications.
Our company specializes in conducting high-quality analytical studies, ensuring accuracy and reliability in regulatory submissions.
Zepto’s CRO team is ready and equipped to support your product submissions every step of the way. Our experiences include FDA Emergency Use Authorization (EUA) & 510(k) submissions as well as submissions for countries outside of the United States.
Zepto is a proudly ITAP qualified testing vendor. Zepto’s successful completion of ITAP EUA validation studies to support FDA EUA submission of over-the-counter assays for the detection of COVID-19, Flu A and Flu B, with a tight timeline of 4-6 weeks received positive feedback from both sponsor as well as the ITAP regulatory team.
Independent Test Assessment Program (ITAP) is a part of The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program. ITAP has helped bring to market more than 3.8 billion tests and has helped more than a dozen industry participants to obtain FDA authorization and to commercialize their tests within the United States. For more information, please visit their website here.
Our facilities includes an onsite high-complexity CLIA laboratory and testing laboratory as well as a BSL 2+ certified testing laboratory.
Our CRO Team’s Expertise
Our experienced team of expert scientists
Analytical Testing
Zepto Life Technology is a provider of analytical studies with a proven track record in supporting FDA (EUA) and 510(k) applications.
- Regulatory Strategy and Submission Support
- Risk Evaluation
- Product Adjustment Support
- Market Comparison & Customized Reports for- Global Non-U.S. Sale
- Product Validation
- Study design
- Testing protocol drafting
- Robust data review
- Efficient data reporting
- Test report for regulatory submission
- Long-term testing including environmental control & stability
- BSL 2, BSL 2+, BSL 3 pathogens testing
Central Reference Lab Testing
Zepto Life Technology’s onsite high-complexity CLIA laboratory and BSL 2+ testing laboratory is equipped with state-of-the-art instruments.
- High Complexity CLIA Certified Lab
- Trained Professional Staff
- Quick Turnaround and Data Reporting
- Customized Client Reports
- Post Authorization Quality Monitoring Plan/Testing
- QuantStudio 5 Dx RT-PCR System
- BioRad CFX96 RT-PCR Instrument
- Cepheid GeneXpert Instrument
- Thermo Fisher Kingfisher Flex Purification System
- Biosafety Cabinets
- PCR Workstations
- Freezers (< -20 ºC, < -70 ºC)
- Refrigerators
- Environmental Chamber (temperature and humidity)
- Other Laboratory supplies
Our Amazing Clients
Here are some of our past clients whom we have helped on their mission to shape the healthcare landscape!
Interested? Get in Touch!
Send us a request and receive your quote today! Zepto has a proven track record of successful project completions with customized support & consulting tailor made for your team. Reach out to realize your projects today!