SARS_CoV-2 Detection Kits | qRT-PCR Covid-19 Detection Kits | Genomicss

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
Services
Distributors
Kumar & Ballal Exim Private Limited
Ganesh Mahal Complex
K S Rao Road
Mangalore-1
Karnataka, INDIA
 
For South East Asia & India distribution, please contact

Chetan Ravnikar
Vice President