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EHS

Bio-Analytical Laboratory

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Expertise & Capabilities:

  • Experienced team involved in Bio-Analytical Method Development, Method Validation and Project Sample Analysis in compliance with regulatory requirements
  • Experience in conducting Bio-Analytical Assays:
    • Complex assays employing with Sensitive LC-MS/MS
    • Analyte and its Metabolites in Biological matrix
    • Study of Unstable compounds and metabolite back conversion
    • Endogenous molecule methods
    • Derivatization Methods
    • Liposomal molecule methods
    • Chiral molecule methods
  • Dedicated teams to ensure that all work is conducted in compliance with SOPs and all applicable regulatory guidelines with the capability to conduct extensive literature search for difficult assays
  • Validated Methods Library: 300 + methods that are compliant with global regulatory agencies

Infrastructure

  • GLP Compliant Laboratory infrastructure equipped with:
    • LC-MS/MS instruments laboratories
    • Well-equipped Sample preparation and extraction processing laboratory
    • Separate area for Standards/Metabolites Storage and Balance Room
    • Capability to handle Photosensitive/Light-Sensitive Molecules
    • Deep Freezers
    • Cold Room
    • Chemicals/Solvents Storage
    • Bio-Waste Management
    • Documentation
  • Chromatography Systems: 9 LC/MS/MS Systems
  • Sensitive API 4500 equipped with UHPLC System

Biological Sample Storage

  • Sample Storage capacity at -30°C, -20°C and -70°C Temperature in Deep Freezers.
  • Cold Room Storage capacity of more than 2.0 million samples at -20°C Temperature

Regulatory Inspection

Successfully inspected by various regulatory agencies across the globe. Our impeccable regulatory track record is the result of strict adherence to the applicable standard(s) and guidelines laid by facility audits by DCGI, US FDA, MHRA , WHO, NPRA .


Depending on the regulatory requirement - rapid Bioanalytical method development and method validation is carried out.

  • GLP compliant Lab
  • 9 LC-MS/MS systems (ABSCIEX).
  • Deep freezers (maintained at -20°C, -30°C and -70°C) and walk-in freezer (maintained at -20°C) for sample storage.
  • Estimation of drug and/or metabolites in different biological matrices using various extraction techniques - Liquid/Liquid, Solid phase etc.

List of Bioanalytical Methods