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Biocompatibility & Safety Testing	Chemical Characterization & Risk Assessment	Regulatory & Performance Testing
Biocompatibility Tests: Systemic Toxicity (ISO 10993-11) Irritation & Sensitization (ISO 10993-10 & USP) Implantation Testing (ISO 10993-6 & USP) Hemocompatibility Testing (ISO 10993-4) Reproductive & Developmental Toxicity (ISO 10993-3) Carcinogenicity Testing (ISO 10993-3) Pyrogenicity Testing USP Plastics (USP Class IV) In-Vitro Cytotoxicity Testing (ISO 10993-5) In-Vitro Genotoxicity Testing (ISO 10993-5) Sterility Bioburden Testing Bacterial Endotoxin Testing Alternative to Animal Models	Chemical Characterization (ISO 10993-18) Comprehensive Biological and Toxicological Risk Assessment (ISO 10993-17) Extractables & Leachables Studies Impurity / Degradant Toxicity Assessment	Regulatory Documentation & Performance Testing Biological Evaluation Plans (BEP) & Reports (BER) Clinical Testing Support Performance Testing of Devices Package Testing (ISO 11607 compliance) Electronic Safety Testing (EMI/EMC) Risk Assessment & Compliance Support (ISO 14971)

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Discovery Chemistry

Discovery Biology

Regulatory Support

In vivo

In vitro

Toxicology

CMC(Chemistry, Manufacturing & Controls) & Formulation

API process development & scale-up
Solid-state & formulation science
Formulation development
Excipients selection & compatibility
Stability & shelf-life studies

Analytics & Bioanalytical Chemistry

Analytics method development & validation(ICH Q2)
Impurity profiling & quantitation
Residual solvents & elemental impurities (ICH Q3C / Q3D)
Dissolution, content uniformity, assay, potency
Batch release testing, CoA, stability-indicating methods
Specialized Routine Testing
Enzyme activity assays (standardized QC panels)
Heparin potency & purity testing
Low Molecular Weight Heparin (LMWH) assays including Enoxaparin

Non-clinical PK studies PK/PD studies & modelling

Efficacy (disease) models Dose-range finding and proof-of-concept studies

Biodistribution & mass-balance (ADME) studies

In vivo DDI/interaction confirmation t

Target validation & target engagement

Cell-based functional assays

In vitro ADME (DMPK)

Permeability & transporter assays

In vitro mechanistic safety screens

Biomarker & PD assay development

Clinical pathology & biomarker panels

GLP bioanalysis / LC-MS/MS capabilities

Biostatistics, data analysis, PK/PD & modelling teams

Drug-drug interaction (DDI) studies

Non-Clinical Safety Testing

In vitro genotoxicity

GLP toxicology studies

Genotoxicity & carcinogenicity

Reproductive & developmental toxicity

Immunotoxicity, hypersensitivity & local tolerance

Histopathology & toxicologic pathology

Impurity toxicology & metabolite safety assessments

Regulatory strategy & agency interaction support

ICH guideline compliance & CTD compilation

Impurity qualification & safety-related assessments

Environmental Risk Assessment (ERA)

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In Vivo Animal Studies	Microbiology Testing	Biopharmaceutical Characterization & Functional Assays	Cellular & Molecular Lab Assays
Acute toxicity studies Sub-acute and sub-chronic toxicity studies Chronic toxicity studies Maximum tolerated dose (MTD) determination Dose range finding (DRF) studies Pharmacokinetic (PK) and bioavailability studies Disease and efficacy models Repeated dose toxicity assessments	Microbiology & Resistance Studies Sterility testing (per ISO, USP, or pharmacopeial standards) Bioburden determination and monitoring Endotoxin testing (Limulus Amebocyte Lysate, LAL) Antibacterial and antifungal activity assays Microbial identification / strain typing Resistance profile screening Environmental monitoring (surfaces, air, water) Preservative efficacy (challenge test)	Cell-based & Functional Bioassays (Potency, Immunogenicity, Cytotoxicity) Mechanism of Action Studies (Receptor Binding, Signal Transduction) Molecular & Analytical Characterization (HCP, Residual DNA/RNA, Binding Studies) In Vitro ADME & Stability Studies (Serum/Plasma Stability, Permeability, Protein Degradation) Stability & Shelf-life Studies (Accelerated, Real-Time, Forced Degradation) Immunology & Bioanalytical Platforms (Cytokine Release, Immunophenotyping, PK/PD Analysis) Pathology, Microbiology & Virology Support (Histopathology, Sterility, Mycoplasma, Endotoxin Testing) Custom Assay Development & Validation	Cytotoxicity Assays (MTT, XTT, LDH, WST-1, Neutral Red) Cell Proliferation and Apoptosis Studies Genetic Toxicology Tests (Ames Test, Micronucleus Assay, Chromosome Aberration) ADME Cellular Models (Caco-2 Permeability, Hepatocyte Metabolism) Reporter Gene Assays (Mechanism-of-Action) Flow Cytometry-based Immunophenotyping Custom Cell-Based Assay Development

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Safety & Toxicological Testing	Clinical, Efficacy, and Mechanistic Studies	Purity & Stability Testing
Skin Irritation and Sensitization (OECD 404, LLNA) Eye Irritation and Corrosion (BCOP, ICE) Phototoxicity and Photoallergenicity Acute and Repeated Dose Toxicity Mutagenicity and Genotoxicity (Ames test, Micronucleus) Dermal Absorption Studies Preservative Efficacy Challenge Test Microbial Limits and Endotoxin Testing Heavy Metals and Residual Solvent Analysis Analysis of Restricted and Prohibited Substances	Dermatological Safety: Patch Tests (HRIPT, Cumulative Irritation) Clinical Efficacy: Moisturization, Anti-aging, Skin Brightening, Anti-acne, Hair Growth Discovery Biology: Collagen/Elastin Synthesis, Melanin Inhibition, Anti-inflammatory Assays Microbiome Modulation and Bioassays In Vitro ADME & Permeation: Skin Absorption, Barrier Function Custom Assay Development & Claim Validation	Purity, Impurities & Stability Testing (ICH & USP guidelines) Physical Properties: pH, Viscosity, Spreadability, Particle Size, Zeta Potential Ingredient Profiling (HPLC, LC-MS, GC-MS, NMR) Shelf-life and Photostability Testing

Edit Template

Physicochemical Characterization	Biological Efficacy	Toxicology Studies	Regulatory Support
Purity & Impurity Profiling Physicochemical Property Testing Solubility, Vapor Pressure, Partition Coefficient, Stability Spectroscopic & Analytical Method Development (HPLC, GC, MS, NMR) Viscosity, Particle Size, Zeta Potential	Microbiology & Resistance Studies Bioactivity & Efficacy Testing (antibacterial, antifungal, insecticidal, herbicidal)	In Vivo Toxicology Studies Genotoxicity Testing Ecotoxicity Testing	Impurity / Degradant Toxicity Assessment Stability & Shelf-Life Studies Chemical Risk & Exposure Assessment Custom Assay Development & Validation

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Preclinical Efficacy & Mechanistic Studies	Toxicology & Safety Assessment	Regulatory & Compliance Support
In vivo Nutraceutical Efficacy Glycemic Index & Glycemic Load Estimation In vitro Nutraceutical Bioactivity Probiotics Custom Study Designs	Acute Oral Toxicity Studies Sub-chronic Toxicity Studies Genotoxicity Testing Reproductive & Developmental Toxicity Skin & Mucosal Irritation Testing Toxicological Risk Assessment	Novel Food & Dietary Ingredient Submissions Nutritional Label Validation & Claims Substantiation Risk Assessment

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Contact Us
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Home
About

MEDICAL DEVICES

PHARMACEUTICALS

BIOPHARMACEUTICALS

COSMETICS

AGROCHEMICAL

NUTRACEUTICALS

Biocompatibility & Safety Testing	Chemical Characterization & Risk Assessment	Regulatory & Performance Testing
Biocompatibility Tests: Systemic Toxicity (ISO 10993-11) Irritation & Sensitization (ISO 10993-10 & USP) Implantation Testing (ISO 10993-6 & USP) Hemocompatibility Testing (ISO 10993-4) Reproductive & Developmental Toxicity (ISO 10993-3) Carcinogenicity Testing (ISO 10993-3) Pyrogenicity Testing USP Plastics (USP Class IV) In-Vitro Cytotoxicity Testing (ISO 10993-5) In-Vitro Genotoxicity Testing (ISO 10993-5) Sterility Bioburden Testing Bacterial Endotoxin Testing Alternative to Animal Models	Chemical Characterization (ISO 10993-18) Comprehensive Biological and Toxicological Risk Assessment (ISO 10993-17) Extractables & Leachables Studies Impurity / Degradant Toxicity Assessment	Regulatory Documentation & Performance Testing Biological Evaluation Plans (BEP) & Reports (BER) Clinical Testing Support Performance Testing of Devices Package Testing (ISO 11607 compliance) Electronic Safety Testing (EMI/EMC) Risk Assessment & Compliance Support (ISO 14971)

Edit Template

Discovery Chemistry

Discovery Biology

Regulatory Support

In vivo

In vitro

Toxicology

CMC(Chemistry, Manufacturing & Controls) & Formulation

API process development & scale-up
Solid-state & formulation science
Formulation development
Excipients selection & compatibility
Stability & shelf-life studies

Analytics & Bioanalytical Chemistry

Analytics method development & validation(ICH Q2)
Impurity profiling & quantitation
Residual solvents & elemental impurities (ICH Q3C / Q3D)
Dissolution, content uniformity, assay, potency
Batch release testing, CoA, stability-indicating methods
Specialized Routine Testing
Enzyme activity assays (standardized QC panels)
Heparin potency & purity testing
Low Molecular Weight Heparin (LMWH) assays including Enoxaparin

Non-clinical PK studies PK/PD studies & modelling

Efficacy (disease) models Dose-range finding and proof-of-concept studies

Biodistribution & mass-balance (ADME) studies

In vivo DDI/interaction confirmation t

Target validation & target engagement

Cell-based functional assays

In vitro ADME (DMPK)

Permeability & transporter assays

In vitro mechanistic safety screens

Biomarker & PD assay development

Clinical pathology & biomarker panels

GLP bioanalysis / LC-MS/MS capabilities

Biostatistics, data analysis, PK/PD & modelling teams

Drug-drug interaction (DDI) studies

Non-Clinical Safety Testing

In vitro genotoxicity

GLP toxicology studies

Genotoxicity & carcinogenicity

Reproductive & developmental toxicity

Immunotoxicity, hypersensitivity & local tolerance

Histopathology & toxicologic pathology

Impurity toxicology & metabolite safety assessments

Regulatory strategy & agency interaction support

ICH guideline compliance & CTD compilation

Impurity qualification & safety-related assessments

Environmental Risk Assessment (ERA)

Edit Template

In Vivo Animal Studies	Microbiology Testing	Biopharmaceutical Characterization & Functional Assays	Cellular & Molecular Lab Assays
Acute toxicity studies Sub-acute and sub-chronic toxicity studies Chronic toxicity studies Maximum tolerated dose (MTD) determination Dose range finding (DRF) studies Pharmacokinetic (PK) and bioavailability studies Disease and efficacy models Repeated dose toxicity assessments	Microbiology & Resistance Studies Sterility testing (per ISO, USP, or pharmacopeial standards) Bioburden determination and monitoring Endotoxin testing (Limulus Amebocyte Lysate, LAL) Antibacterial and antifungal activity assays Microbial identification / strain typing Resistance profile screening Environmental monitoring (surfaces, air, water) Preservative efficacy (challenge test)	Cell-based & Functional Bioassays (Potency, Immunogenicity, Cytotoxicity) Mechanism of Action Studies (Receptor Binding, Signal Transduction) Molecular & Analytical Characterization (HCP, Residual DNA/RNA, Binding Studies) In Vitro ADME & Stability Studies (Serum/Plasma Stability, Permeability, Protein Degradation) Stability & Shelf-life Studies (Accelerated, Real-Time, Forced Degradation) Immunology & Bioanalytical Platforms (Cytokine Release, Immunophenotyping, PK/PD Analysis) Pathology, Microbiology & Virology Support (Histopathology, Sterility, Mycoplasma, Endotoxin Testing) Custom Assay Development & Validation	Cytotoxicity Assays (MTT, XTT, LDH, WST-1, Neutral Red) Cell Proliferation and Apoptosis Studies Genetic Toxicology Tests (Ames Test, Micronucleus Assay, Chromosome Aberration) ADME Cellular Models (Caco-2 Permeability, Hepatocyte Metabolism) Reporter Gene Assays (Mechanism-of-Action) Flow Cytometry-based Immunophenotyping Custom Cell-Based Assay Development

Edit Template

Safety & Toxicological Testing	Clinical, Efficacy, and Mechanistic Studies	Purity & Stability Testing
Skin Irritation and Sensitization (OECD 404, LLNA) Eye Irritation and Corrosion (BCOP, ICE) Phototoxicity and Photoallergenicity Acute and Repeated Dose Toxicity Mutagenicity and Genotoxicity (Ames test, Micronucleus) Dermal Absorption Studies Preservative Efficacy Challenge Test Microbial Limits and Endotoxin Testing Heavy Metals and Residual Solvent Analysis Analysis of Restricted and Prohibited Substances	Dermatological Safety: Patch Tests (HRIPT, Cumulative Irritation) Clinical Efficacy: Moisturization, Anti-aging, Skin Brightening, Anti-acne, Hair Growth Discovery Biology: Collagen/Elastin Synthesis, Melanin Inhibition, Anti-inflammatory Assays Microbiome Modulation and Bioassays In Vitro ADME & Permeation: Skin Absorption, Barrier Function Custom Assay Development & Claim Validation	Purity, Impurities & Stability Testing (ICH & USP guidelines) Physical Properties: pH, Viscosity, Spreadability, Particle Size, Zeta Potential Ingredient Profiling (HPLC, LC-MS, GC-MS, NMR) Shelf-life and Photostability Testing

Edit Template

Physicochemical Characterization	Biological Efficacy	Toxicology Studies	Regulatory Support
Purity & Impurity Profiling Physicochemical Property Testing Solubility, Vapor Pressure, Partition Coefficient, Stability Spectroscopic & Analytical Method Development (HPLC, GC, MS, NMR) Viscosity, Particle Size, Zeta Potential	Microbiology & Resistance Studies Bioactivity & Efficacy Testing (antibacterial, antifungal, insecticidal, herbicidal)	In Vivo Toxicology Studies Genotoxicity Testing Ecotoxicity Testing	Impurity / Degradant Toxicity Assessment Stability & Shelf-Life Studies Chemical Risk & Exposure Assessment Custom Assay Development & Validation

Edit Template

Preclinical Efficacy & Mechanistic Studies	Toxicology & Safety Assessment	Regulatory & Compliance Support
In vivo Nutraceutical Efficacy Glycemic Index & Glycemic Load Estimation In vitro Nutraceutical Bioactivity Probiotics Custom Study Designs	Acute Oral Toxicity Studies Sub-chronic Toxicity Studies Genotoxicity Testing Reproductive & Developmental Toxicity Skin & Mucosal Irritation Testing Toxicological Risk Assessment	Novel Food & Dietary Ingredient Submissions Nutritional Label Validation & Claims Substantiation Risk Assessment

Edit Template

Contact Us
Request Quote

Home
About

MEDICAL DEVICES

PHARMACEUTICALS

BIOPHARMACEUTICALS

COSMETICS

AGROCHEMICAL

NUTRACEUTICALS

Biocompatibility & Safety Testing	Chemical Characterization & Risk Assessment	Regulatory & Performance Testing
Biocompatibility Tests: Systemic Toxicity (ISO 10993-11) Irritation & Sensitization (ISO 10993-10 & USP) Implantation Testing (ISO 10993-6 & USP) Hemocompatibility Testing (ISO 10993-4) Reproductive & Developmental Toxicity (ISO 10993-3) Carcinogenicity Testing (ISO 10993-3) Pyrogenicity Testing USP Plastics (USP Class IV) In-Vitro Cytotoxicity Testing (ISO 10993-5) In-Vitro Genotoxicity Testing (ISO 10993-5) Sterility Bioburden Testing Bacterial Endotoxin Testing Alternative to Animal Models	Chemical Characterization (ISO 10993-18) Comprehensive Biological and Toxicological Risk Assessment (ISO 10993-17) Extractables & Leachables Studies Impurity / Degradant Toxicity Assessment	Regulatory Documentation & Performance Testing Biological Evaluation Plans (BEP) & Reports (BER) Clinical Testing Support Performance Testing of Devices Package Testing (ISO 11607 compliance) Electronic Safety Testing (EMI/EMC) Risk Assessment & Compliance Support (ISO 14971)

Edit Template

Discovery Chemistry

Discovery Biology

Regulatory Support

In vivo

In vitro

Toxicology

CMC(Chemistry, Manufacturing & Controls) & Formulation

API process development & scale-up
Solid-state & formulation science
Formulation development
Excipients selection & compatibility
Stability & shelf-life studies

Analytics & Bioanalytical Chemistry

Analytics method development & validation(ICH Q2)
Impurity profiling & quantitation
Residual solvents & elemental impurities (ICH Q3C / Q3D)
Dissolution, content uniformity, assay, potency
Batch release testing, CoA, stability-indicating methods
Specialized Routine Testing
Enzyme activity assays (standardized QC panels)
Heparin potency & purity testing
Low Molecular Weight Heparin (LMWH) assays including Enoxaparin

Non-clinical PK studies PK/PD studies & modelling

Efficacy (disease) models Dose-range finding and proof-of-concept studies

Biodistribution & mass-balance (ADME) studies

In vivo DDI/interaction confirmation t

Target validation & target engagement

Cell-based functional assays

In vitro ADME (DMPK)

Permeability & transporter assays

In vitro mechanistic safety screens

Biomarker & PD assay development

Clinical pathology & biomarker panels

GLP bioanalysis / LC-MS/MS capabilities

Biostatistics, data analysis, PK/PD & modelling teams

Drug-drug interaction (DDI) studies

Non-Clinical Safety Testing

In vitro genotoxicity

GLP toxicology studies

Genotoxicity & carcinogenicity

Reproductive & developmental toxicity

Immunotoxicity, hypersensitivity & local tolerance

Histopathology & toxicologic pathology

Impurity toxicology & metabolite safety assessments

Regulatory strategy & agency interaction support

ICH guideline compliance & CTD compilation

Impurity qualification & safety-related assessments

Environmental Risk Assessment (ERA)

Edit Template

In Vivo Animal Studies	Microbiology Testing	Biopharmaceutical Characterization & Functional Assays	Cellular & Molecular Lab Assays
Acute toxicity studies Sub-acute and sub-chronic toxicity studies Chronic toxicity studies Maximum tolerated dose (MTD) determination Dose range finding (DRF) studies Pharmacokinetic (PK) and bioavailability studies Disease and efficacy models Repeated dose toxicity assessments	Microbiology & Resistance Studies Sterility testing (per ISO, USP, or pharmacopeial standards) Bioburden determination and monitoring Endotoxin testing (Limulus Amebocyte Lysate, LAL) Antibacterial and antifungal activity assays Microbial identification / strain typing Resistance profile screening Environmental monitoring (surfaces, air, water) Preservative efficacy (challenge test)	Cell-based & Functional Bioassays (Potency, Immunogenicity, Cytotoxicity) Mechanism of Action Studies (Receptor Binding, Signal Transduction) Molecular & Analytical Characterization (HCP, Residual DNA/RNA, Binding Studies) In Vitro ADME & Stability Studies (Serum/Plasma Stability, Permeability, Protein Degradation) Stability & Shelf-life Studies (Accelerated, Real-Time, Forced Degradation) Immunology & Bioanalytical Platforms (Cytokine Release, Immunophenotyping, PK/PD Analysis) Pathology, Microbiology & Virology Support (Histopathology, Sterility, Mycoplasma, Endotoxin Testing) Custom Assay Development & Validation	Cytotoxicity Assays (MTT, XTT, LDH, WST-1, Neutral Red) Cell Proliferation and Apoptosis Studies Genetic Toxicology Tests (Ames Test, Micronucleus Assay, Chromosome Aberration) ADME Cellular Models (Caco-2 Permeability, Hepatocyte Metabolism) Reporter Gene Assays (Mechanism-of-Action) Flow Cytometry-based Immunophenotyping Custom Cell-Based Assay Development

Edit Template

Safety & Toxicological Testing	Clinical, Efficacy, and Mechanistic Studies	Purity & Stability Testing
Skin Irritation and Sensitization (OECD 404, LLNA) Eye Irritation and Corrosion (BCOP, ICE) Phototoxicity and Photoallergenicity Acute and Repeated Dose Toxicity Mutagenicity and Genotoxicity (Ames test, Micronucleus) Dermal Absorption Studies Preservative Efficacy Challenge Test Microbial Limits and Endotoxin Testing Heavy Metals and Residual Solvent Analysis Analysis of Restricted and Prohibited Substances	Dermatological Safety: Patch Tests (HRIPT, Cumulative Irritation) Clinical Efficacy: Moisturization, Anti-aging, Skin Brightening, Anti-acne, Hair Growth Discovery Biology: Collagen/Elastin Synthesis, Melanin Inhibition, Anti-inflammatory Assays Microbiome Modulation and Bioassays In Vitro ADME & Permeation: Skin Absorption, Barrier Function Custom Assay Development & Claim Validation	Purity, Impurities & Stability Testing (ICH & USP guidelines) Physical Properties: pH, Viscosity, Spreadability, Particle Size, Zeta Potential Ingredient Profiling (HPLC, LC-MS, GC-MS, NMR) Shelf-life and Photostability Testing

Edit Template

Physicochemical Characterization	Biological Efficacy	Toxicology Studies	Regulatory Support
Purity & Impurity Profiling Physicochemical Property Testing Solubility, Vapor Pressure, Partition Coefficient, Stability Spectroscopic & Analytical Method Development (HPLC, GC, MS, NMR) Viscosity, Particle Size, Zeta Potential	Microbiology & Resistance Studies Bioactivity & Efficacy Testing (antibacterial, antifungal, insecticidal, herbicidal)	In Vivo Toxicology Studies Genotoxicity Testing Ecotoxicity Testing	Impurity / Degradant Toxicity Assessment Stability & Shelf-Life Studies Chemical Risk & Exposure Assessment Custom Assay Development & Validation

Edit Template

Preclinical Efficacy & Mechanistic Studies	Toxicology & Safety Assessment	Regulatory & Compliance Support
In vivo Nutraceutical Efficacy Glycemic Index & Glycemic Load Estimation In vitro Nutraceutical Bioactivity Probiotics Custom Study Designs	Acute Oral Toxicity Studies Sub-chronic Toxicity Studies Genotoxicity Testing Reproductive & Developmental Toxicity Skin & Mucosal Irritation Testing Toxicological Risk Assessment	Novel Food & Dietary Ingredient Submissions Nutritional Label Validation & Claims Substantiation Risk Assessment

Edit Template

Contact Us
Request Quote

Home
About

MEDICAL DEVICES

PHARMACEUTICALS

BIOPHARMACEUTICALS

COSMETICS

AGROCHEMICAL

NUTRACEUTICALS

Biocompatibility & Safety Testing	Chemical Characterization & Risk Assessment	Regulatory & Performance Testing
Biocompatibility Tests: Systemic Toxicity (ISO 10993-11) Irritation & Sensitization (ISO 10993-10 & USP) Implantation Testing (ISO 10993-6 & USP) Hemocompatibility Testing (ISO 10993-4) Reproductive & Developmental Toxicity (ISO 10993-3) Carcinogenicity Testing (ISO 10993-3) Pyrogenicity Testing USP Plastics (USP Class IV) In-Vitro Cytotoxicity Testing (ISO 10993-5) In-Vitro Genotoxicity Testing (ISO 10993-5) Sterility Bioburden Testing Bacterial Endotoxin Testing Alternative to Animal Models	Chemical Characterization (ISO 10993-18) Comprehensive Biological and Toxicological Risk Assessment (ISO 10993-17) Extractables & Leachables Studies Impurity / Degradant Toxicity Assessment	Regulatory Documentation & Performance Testing Biological Evaluation Plans (BEP) & Reports (BER) Clinical Testing Support Performance Testing of Devices Package Testing (ISO 11607 compliance) Electronic Safety Testing (EMI/EMC) Risk Assessment & Compliance Support (ISO 14971)

Edit Template

Discovery Chemistry

Discovery Biology

Regulatory Support

In vivo

In vitro

Toxicology

CMC(Chemistry, Manufacturing & Controls) & Formulation

API process development & scale-up
Solid-state & formulation science
Formulation development
Excipients selection & compatibility
Stability & shelf-life studies

Analytics & Bioanalytical Chemistry

Analytics method development & validation(ICH Q2)
Impurity profiling & quantitation
Residual solvents & elemental impurities (ICH Q3C / Q3D)
Dissolution, content uniformity, assay, potency
Batch release testing, CoA, stability-indicating methods
Specialized Routine Testing
Enzyme activity assays (standardized QC panels)
Heparin potency & purity testing
Low Molecular Weight Heparin (LMWH) assays including Enoxaparin

Non-clinical PK studies PK/PD studies & modelling

Efficacy (disease) models Dose-range finding and proof-of-concept studies

Biodistribution & mass-balance (ADME) studies

In vivo DDI/interaction confirmation t

Target validation & target engagement

Cell-based functional assays

In vitro ADME (DMPK)

Permeability & transporter assays

In vitro mechanistic safety screens

Biomarker & PD assay development

Clinical pathology & biomarker panels

GLP bioanalysis / LC-MS/MS capabilities

Biostatistics, data analysis, PK/PD & modelling teams

Drug-drug interaction (DDI) studies

Non-Clinical Safety Testing

In vitro genotoxicity

GLP toxicology studies

Genotoxicity & carcinogenicity

Reproductive & developmental toxicity

Immunotoxicity, hypersensitivity & local tolerance

Histopathology & toxicologic pathology

Impurity toxicology & metabolite safety assessments

Regulatory strategy & agency interaction support

ICH guideline compliance & CTD compilation

Impurity qualification & safety-related assessments

Environmental Risk Assessment (ERA)

Edit Template

In Vivo Animal Studies	Microbiology Testing	Biopharmaceutical Characterization & Functional Assays	Cellular & Molecular Lab Assays
Acute toxicity studies Sub-acute and sub-chronic toxicity studies Chronic toxicity studies Maximum tolerated dose (MTD) determination Dose range finding (DRF) studies Pharmacokinetic (PK) and bioavailability studies Disease and efficacy models Repeated dose toxicity assessments	Microbiology & Resistance Studies Sterility testing (per ISO, USP, or pharmacopeial standards) Bioburden determination and monitoring Endotoxin testing (Limulus Amebocyte Lysate, LAL) Antibacterial and antifungal activity assays Microbial identification / strain typing Resistance profile screening Environmental monitoring (surfaces, air, water) Preservative efficacy (challenge test)	Cell-based & Functional Bioassays (Potency, Immunogenicity, Cytotoxicity) Mechanism of Action Studies (Receptor Binding, Signal Transduction) Molecular & Analytical Characterization (HCP, Residual DNA/RNA, Binding Studies) In Vitro ADME & Stability Studies (Serum/Plasma Stability, Permeability, Protein Degradation) Stability & Shelf-life Studies (Accelerated, Real-Time, Forced Degradation) Immunology & Bioanalytical Platforms (Cytokine Release, Immunophenotyping, PK/PD Analysis) Pathology, Microbiology & Virology Support (Histopathology, Sterility, Mycoplasma, Endotoxin Testing) Custom Assay Development & Validation	Cytotoxicity Assays (MTT, XTT, LDH, WST-1, Neutral Red) Cell Proliferation and Apoptosis Studies Genetic Toxicology Tests (Ames Test, Micronucleus Assay, Chromosome Aberration) ADME Cellular Models (Caco-2 Permeability, Hepatocyte Metabolism) Reporter Gene Assays (Mechanism-of-Action) Flow Cytometry-based Immunophenotyping Custom Cell-Based Assay Development

Edit Template

Safety & Toxicological Testing	Clinical, Efficacy, and Mechanistic Studies	Purity & Stability Testing
Skin Irritation and Sensitization (OECD 404, LLNA) Eye Irritation and Corrosion (BCOP, ICE) Phototoxicity and Photoallergenicity Acute and Repeated Dose Toxicity Mutagenicity and Genotoxicity (Ames test, Micronucleus) Dermal Absorption Studies Preservative Efficacy Challenge Test Microbial Limits and Endotoxin Testing Heavy Metals and Residual Solvent Analysis Analysis of Restricted and Prohibited Substances	Dermatological Safety: Patch Tests (HRIPT, Cumulative Irritation) Clinical Efficacy: Moisturization, Anti-aging, Skin Brightening, Anti-acne, Hair Growth Discovery Biology: Collagen/Elastin Synthesis, Melanin Inhibition, Anti-inflammatory Assays Microbiome Modulation and Bioassays In Vitro ADME & Permeation: Skin Absorption, Barrier Function Custom Assay Development & Claim Validation	Purity, Impurities & Stability Testing (ICH & USP guidelines) Physical Properties: pH, Viscosity, Spreadability, Particle Size, Zeta Potential Ingredient Profiling (HPLC, LC-MS, GC-MS, NMR) Shelf-life and Photostability Testing

Edit Template

Physicochemical Characterization	Biological Efficacy	Toxicology Studies	Regulatory Support
Purity & Impurity Profiling Physicochemical Property Testing Solubility, Vapor Pressure, Partition Coefficient, Stability Spectroscopic & Analytical Method Development (HPLC, GC, MS, NMR) Viscosity, Particle Size, Zeta Potential	Microbiology & Resistance Studies Bioactivity & Efficacy Testing (antibacterial, antifungal, insecticidal, herbicidal)	In Vivo Toxicology Studies Genotoxicity Testing Ecotoxicity Testing	Impurity / Degradant Toxicity Assessment Stability & Shelf-Life Studies Chemical Risk & Exposure Assessment Custom Assay Development & Validation

Edit Template

Preclinical Efficacy & Mechanistic Studies	Toxicology & Safety Assessment	Regulatory & Compliance Support
In vivo Nutraceutical Efficacy Glycemic Index & Glycemic Load Estimation In vitro Nutraceutical Bioactivity Probiotics Custom Study Designs	Acute Oral Toxicity Studies Sub-chronic Toxicity Studies Genotoxicity Testing Reproductive & Developmental Toxicity Skin & Mucosal Irritation Testing Toxicological Risk Assessment	Novel Food & Dietary Ingredient Submissions Nutritional Label Validation & Claims Substantiation Risk Assessment

Edit Template

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Request Quote

Novel Food & Dietary Ingredient Submissions

By aalbioresearchadmin / November 25, 2025

Prepares scientific dossiers, safety summaries, toxicology data, and regulatory documentation for novel ingredients, enzymes, botanicals, and fortified foods.