CLIA ENVIRONMENT
A WORLD OF DATA DRIVEN INSIGHTS
MOgene delivers precise research and clinical insights for our customers based on decades of experience offering comprehensive, highly customized, and data-driven genomic solutions
Droplet Digital PCR Applications for Cell and Gene Therapy Unrivaled Precision and Accuracy for Quality Manufacturing
MOgene CLIA Certificate
CLIA ENVIRONMENT
As a CLIA certified genomic service provider, MOgene can support healthcare professionals in successfully carrying out a wide array of genomic testing. We will work with your clinical and regulatory personnel to define the project objectives and workflow including development of “Advanced diagnostic laboratory test” (ADLT) genomic assays. MOgene team can provide support throughout the lifecycle of your project, starting with a “research” oriented projects leading to developing a market-ready ADLT, including validation of various analytical stages of the pipeline. We also take extra steps to that all of your data and associated information is securely stored.
Additional information on CLIA accreditation
Quality and safety
The Quality Commitment From MOgene
Regulatory Services
MOgene has an established reputation of complying with relevant national and international quality compliance regulations.
- Audit ready for clients with routine internal quality audits
- GLP compliance per FDA 21 CFR Part 58 and Part 11
- Active CAPA program for process improvement
- CLIA Certification
Quality Management System
MOgene has a robust Quality Management System (QMS) detailed in a manual that ensures compliance for quality monitoring and improvement.
- Transparent and routine communications on project timelines and deliverables
- Complete documentation of standard operating procedures (SOPs) and 100% QC of data
- Rigorous sample management process
BioSafety
Our Biosafety practices enable us to provide services for early R&D and market release studies for pathogens that require BSL-2+ facilities.
- Higher levels of lab safety for antimicrobial, human and animal health vaccine development
- Dedicated BSL-2+ Lab and pre-amplification room for your clinical studies
- Trained personnel to handle BSL-2+ level agents
- UNIDIRECTIONAL workflow
Security and Data Protection
MOgene considers safety and confidentiality a top priority for our client’s data.
- 24/7/365 temperature and humidity monitoring
- Individually coded key access to labs
- Secured access to data records
- Daily back-up of data
OUR HISTORY SPEAKS FOR ITSELF
Supporting Genomic Studies Since 2004
Industry Leading Experienced Team
More Than 150 Citations in Peer-reviewed Journals
CONTACT MOGENE
To contact MOgene or request a quote click the links below
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