We serve to CLIA Testing Diagnostic Labs, Health Care Providers, Physicians, Biomedical Researchers, Scientists, Laboratory Technologists, Regulatory Agencies (US-FDA/EMA/WHO/MHRA/ANVISA and Other Regulatory Bodies). We bring extensive experience in CLI, CAP, GLP, GMP, and GCC.
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Kit development, design, method validation, reagents qualification, equipment qualification, Quality By Design, Quality Management Systems for Devices, Quality Risk Management, Continuous Improvement (Six Sigma Methodologies).
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Provide CLIA/CAP, GLP, GCP, GMP Services
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Validation of facilities, Equipment, and Analytical Methods
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All area of Microbiology including Environmental Monitoring, and Sterility Manufacturing and Assurance
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Follow and Train Compliance in Biological Safety: BSL -1 to BSL-4 Classification
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Solve the problems in a timely and cost-effective manner
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Help develop and submit regulatory for approvals
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We work with our client needs, budget and timelines
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Our experts train in diagnostic kit usage, BSL safety, analysis and data interpretation
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Validated Software and training
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Regulatory package preparation and submission
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Quality Management Systems and Quality Risk Management
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AE complaints are investigated in a timely manner and report closure
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Reference reagents development, standardization, qualification.
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Continuous Improvements
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Validation of test methods
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Qualification of Equipment
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21 CFR Part 11
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Data Integrity, reliability, compliance
