Services
We support your journey to develop new physical, chemical and biological products that enhance the quality of human life. We collaborate with you to ensure that your products are safe to use and compliant to the regulatory parameters through rigorous testing.
Our quality assurance team works to maintain quality as per GLP guidelines and ensures that our studies meet regulatory standards.
🧪 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.
Some relevant Guidelines: OECD TG 407, 408, 410, 411; ICH M3(R2), S6(R1);ISO 10993 series.
Pharmacology:
Conduct in vivo and in vitro studies to demonstrate therapeutic potential and mechanisms of action.
Some relevant 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.
This is the heading
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).
🧪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.
Pharmacology:
Conduct in vivo and in vitro studies to demonstrate therapeutic potential and
mechanisms of action.
Bioanalytical:
Perform pharmacokinetic (PK), toxicokinetic (TK), and biomarker analysis
using validated LC-MS/MS methods.
🧫 Medical Devices
We support the biological safety and regulatory validation of devices intended to improve human health and quality of life.
Toxicology:
Perform safety testing and toxicokinetic studies for device-related materials and extractables when required.
Microbiology/Sterility Testing:
Perform sterility, bioburden, and endotoxin testing to ensure compliance with pharmacopeial and ISO standards.
Analytical Chemistry:
Analyse leachables and extractables to assess chemical safety of device
materials.
🌾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 in compliance with OECD and EPA guidelines.
Genotoxicity/Mutagenicity:
Identify potential DNA or chromosomal damage caused by agrochemicals
Analytical Chemistry:
Perform residue analysis, method validation, and formulation stability testing for regulatory submissions.
🧪 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.
Some relevant Guidelines: OECD TG 407, 408, 410, 411; ICH M3(R2), S6(R1);ISO 10993 series.
Pharmacology:
Conduct in vivo and in vitro studies to demonstrate therapeutic potential and mechanisms of action.
Some relevant 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.
This is the heading
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 chemicalsthrough comprehensive toxicological and environmental studies.
Toxicology:
Conduct acute, sub-chronic, and chronic exposure studies in compliance with OECD and EPA guidelines.
Guidelines: OECD TG 401, 402, 408, 414, 421; EPA OPPTS Series 870
Genotoxicity/Mutagenicity:
Identify potential DNA or chromosomal damage caused by agrochemicals or additives.
Guidelines: OECD TG 471, 473, 474; ICH S2(R1)
Analytical Chemistry:
Perform residue analysis, method validation, and formulation stability testing for regulatory submissions.
Guidelines: OECD GLP 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.
Guidelines: OECD TG 301, 302, 308, 309; EPA guidelines
Additional note: As we develop our in-house facility for complaint ecotoxicology studies, we currently partner with another lab for this testing.
🧴 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; ICH S2(R1)
Pathology:
Provides detailed tissue evaluations to detect sub-lethal and chronic effects of chemical exposure.
Guidelines: OECD TG 407, 408
Facility/department centric
Our well equipped facility and well trained staff can perform a wide range of routine and custom studies to ensure that your product is well tested and well adjusted for suitable use.
Pharmacology studies
These studies investigate the therapeutic effects and mechanisms of action of drug candidates through in vitro and in vivo models. It is essential for demonstrating pharmacodynamic activity, dose-response relationships, and target engagement, forming the scientific basis for efficacy before clinical trials.