Industry We Serve
Pharmaceuticals & Biologics
We ensure the safety, efficacy, and regulatory readiness of new drugs and biologics through comprehensive preclinical evaluation
Toxicology:
Safety studies to assess dose-dependent effects of drug candidates using GLP-compliant protocols across multiple species.
Guidelines: OECD TG 407, 408, 410, 411; ICH M3(R2), ICH S6(R1); ISO 10993 series.
Pharmacology:
Conduct in vivo and in vitro studies to demonstrate therapeutic potential and mechanisms of action.
Guidelines: ICH S7A/B, ICH M3(R2).
Bioanalytical:
Perform pharmacokinetic (PK), toxicokinetic (TK), and biomarker analysis using validated LC-MS/MS methods.
Guidelines: FDA Bioanalytical Method Validation Guidance, EMA Guideline on Bioanalytical Method Validation.
Anatomical Pathology:
Detect tissue-level changes through histopathology, immuno-histochemistry and necropsy to identify drug related effects.
Guidelines: OECD TG 407, 408 (histopathology sections); ISO 10993-6 (implantation effects).
Clinical Pathology:
Assess hematology, biochemistry, and urinalysis parameters to assess systemic toxicity.
Guidelines:OECD TG 407, 408; CLSI guidelines for hematology and biochemistry.
Analytical Chemistry:
Development and validation of methods to measure drug concentration, stability, and purity in test systems.
Guidelines: ICH Q2(R1), USP <1225>, ISO 17025.
Biosafety:
Verify and ensure that the test item is free of adventitious agents and endotoxins to meet regulatory expectations.
Guidelines: USP <85> (Endotoxin Test), FDA Guidance on Biosafety.
Genotoxicity/Mutagenicity:
Inspect for Induced DNA damage and chromosomal abnormalities through standard genotoxicity assays in vitro and in vivo.
Guidelines:OECD TG 471, 473, 474; ICH S2(R1).
Medical Devices
We support the biological safety and regulatory validation of devices intended to improve human health and quality of life.
Biocompatibility :
Analyse cytotoxicity, sensitization, irritation, and systemic toxicity induced by devices, per ISO 10993 series.
Guidelines: ISO 10993-1 to -23, especially ISO 10993-5, -10, -11, -20.
Microbiology/Sterility Testing:
Perform sterility, bioburden, and endotoxin testing to ensure compliance with pharmacopeial and ISO standards.
Guidelines: USP <71> (Sterility), USP <61> (Bioburden), ISO 11737 series.
Analytical Chemistry:
Analyse leachables and extractables to assess chemical safety of device materials.
Guidelines: ISO 10993-18, USP <1663>, <1664>
Toxicology:
Perform safety testing and toxicokinetic studies for device-related materials and extractables when required.
Guidelines: ISO 10993-11, OECD TG 407.
Agrochemicals & Food Additives
We ensure the safe use of pesticides, herbicides, and food-grade chemicals through comprehensive toxicological and environmental studies.
Toxicology:
Conduct acute, sub-chronic, and chronic exposure studies to measure systemic impact.
Guidelines: OECD TG 401, 402, 408, 414, 421 and EPA guidelines.
Genotoxicity/Mutagenicity:
Identify potential DNA or chromosomal damage caused by agrochemicals or additives.
Guidelines: OECD TG 471, 473, 474.
Analytical Chemistry:
Perform residue analysis, method validation, and formulation stability testing for regulatory submissions.
Guidelines: OECD GLP 1, ICH M10, ICH Q1 R1/R2 Principles.
Clinical Pathology:
Detect physiological responses in test systems to detect systemic effects.
Guidelines: OECD TG 407, 408.
Environmental Monitoring:
Measure environmental fate and behavior of agrochemicals to support ecotoxicology safety.
Additional note: As we develop our in-house facility for complaint ecotoxicology studies, we currently partner with another lab for this testing.
Guidelines: OECD TG 301, 302, 308, 309; EPA guidelines
Industrial Chemicals
We support risk assessment and regulatory compliance for chemicals used in manufacturing, construction, and consumer products.
Toxicology:
Analyse the systemic and organ-level toxicity of industrial chemicals across multiple exposure routes.
Guidelines: OECD TG 407, 408, 410, 411; REACH Annexes; EPA OPPTS
Analytical Chemistry:
Supports impurity profiling, stability studies, and material characterization as per regulatory body requirements.
Guidelines: REACH Annexes, EPA, OECD GLP.
Genotoxicity/Mutagenicity:
Determines potential genetic hazards through validated in vitro and in vivo assays.
Guidelines: OECD TG 471, 473, 474.
Pathology:
Provides detailed tissue evaluations to detect sub-lethal and chronic effects of chemical exposure.
Guidelines: OECD TG 407, 408.