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.
- 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).
- Provide CLIA/CAP, GLP, GCP, GMP Services
- Validation of facilities, Equipment, and Analytical Methods
- All area of Microbiology including Environmental Monitoring, and Sterility Manufacturing and Assurance
- Follow and Train Compliance in Biological Safety: BSL -1 to BSL-4 Classification
- Solve the problems in a timely and cost-effective manner
- Help develop and submit regulatory for approvals
- We work with our client needs, budget and timelines
- Our experts train in diagnostic kit usage, BSL safety, analysis and data interpretation
- Validated Software and training
- Regulatory package preparation and submission
- Quality Management Systems and Quality Risk Management
- AE complaints are investigated in a timely manner and report closure
- Reference reagents development, standardization, qualification.
- Continuous Improvements
- Validation of test methods
- Qualification of Equipment
- 21 CFR Part 11
- Data Integrity, reliability, compliance
