Discovery Biology for
Pharmaceutical Testing

Where Science Deciphers Safety and Efficacy

Our Discovery Biology & Toxicology division bridges mechanistic understanding with translational insights, from early pharmacokinetic (PK/PD) studies to full-spectrum non-clinical safety evaluations. Conducted under GLP-compliant conditions, our studies meet global regulatory requirements for FDA, EMA, and CDSCO submissions.

With a team of experienced pharmacologists, toxicologists, and bioanalytical scientists, we deliver dependable preclinical data that drives smarter decisions, de-risks pipelines, and ensures molecules reach clinical trials with confidence.

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Why Discovery Biology & Toxicology Testing Matters

Here’s why these studies are critical in early drug development:

Area of Expertise

Reproductive & Developmental Toxicity

Reproductive & Developmental Toxicity

Evaluates the effects of drug candidates on fertility, embryonic development, and postnatal outcomes. Studies are designed to assess teratogenicity, maternal toxicity, and offspring viability.

Route-Specific Toxicology

Route-Specific Toxicology

  • Inhalation
  • Dermal
  • Ophthalmic Routes
Conducted to assess systemic and local toxicity based on intended route of administration. Provides vital data for formulation-specific or delivery-system safety evaluation.

Histopathology & Toxicologic Pathology

Histopathology & Toxicologic Pathology

Performs microscopic examination of tissues and organs to identify structural or cellular alterations linked to compound exposure. This provides crucial insight into target organ effects and mechanism of toxicity.

Impurity & Metabolite Toxicology

Impurity & Metabolite Toxicology

Evaluates the safety of impurities, degradation products, and unique metabolites in line with ICH M7 and FDA guidance. Ensures that all components, including trace-level entities, meet global toxicological safety thresholds.

Genotoxicity & Carcinogenicity

Genotoxicity & Carcinogenicity

  • In-Vivo Genotoxicity Tests
  • Long-Term Carcinogenicity Studies
Assesses mutagenic, clastogenic, and carcinogenic potential of test substances under prolonged exposure. These studies support regulatory compliance for chronic and life-cycle safety requirements.

GLP Toxicology Studies

GLP Toxicology Studies

  • Acute, Subacute & Repeat-Dose Toxicity (14/28/90-Day)
  • Rodent and Non-Rodent Models
Evaluates systemic effects, target organ toxicity, and dose-dependent responses over time. Data generated forms the backbone of safety assessments for first-in-human dose justification.

In-Vitro Genotoxicity

In-Vitro Genotoxicity

  • Ames Test In-Vitro Micronucleus
  • Chromosomal Aberration Assays
Screens for mutagenic potential using bacterial and mammalian cell-based assays. These early-stage tests detect DNA damage and mutation risks before in-vivo evaluations, ensuring genetic safety at the molecular level.

Drug–Drug Interaction (DDI) Studies

Drug–Drug Interaction (DDI) Studies

  • In-Vitro CYP Induction/Inhibition Assays
  • Transporter Interaction Panels (P-gp, BCRP, OATP)
  • Follow-Up In-Vivo Confirmation Studies
Identifies metabolic and transporter-based drug–drug interactions, enabling early prediction and mitigation of clinical risks.

GLP Bioanalysis & Modelling

GLP Bioanalysis & Modelling

  • GLP-Compliant LC-MS/MS Capabilities
  • Biostatistics, Data Analysis, and PK/PD Modelling
Provides validated quantitative bioanalysis of drug and metabolite levels with expert PK/PD correlation, ensuring reliable interpretation and decision-making across study phases.

Biomarker & Pharmacodynamic (PD) Assay Development

Biomarker & Pharmacodynamic (PD) Assay Development

  • ELISA and Multiplex Immunoassays
  • Proteomic Readouts and Clinical Pathology Panels
Develops and validates biomarker and PD assays that quantify biological effects, supporting efficacy evaluations, mechanism-of-action studies, and translational modelling.

In-Vitro Mechanistic Safety Screens

In-Vitro Mechanistic Safety Screens

  • Cytotoxicity and Mitochondrial Toxicity Assays
  • Early Safety Biomarker Panels
Detects cellular and mitochondrial stress responses, enabling early identification of safety liabilities and guiding compound optimization prior to preclinical studies.

Permeability & Transporter Assays

Permeability & Transporter Assays

  • Caco-2 and PAMPA Permeability
  • Transporter Panels (P-gp, BCRP, OATP)
Determines compound permeability, efflux, and transport mechanisms across biological membranes, providing crucial data for oral absorption and drug–drug interaction potential.

In-Vitro ADME (DMPK) Studies

In-Vitro ADME (DMPK) Studies

  • Microsomal and Hepatocyte Stability
  • Intrinsic Clearance
  • CYP Inhibition/Phenotyping
  • Plasma Protein Binding
  • Metabolic Stability
Assesses drug metabolism and disposition through microsomal and hepatocyte-based models to predict pharmacokinetic performance, enzyme interactions, and bioavailability

Cell-Based Functional Assays

Cell-Based Functional Assays

  • Signaling
  • Viability
  • Reporter Assays
  • Pathway Readouts
Evaluates cellular responses, pathway activation, and downstream signalling through viability, reporter, and mechanistic assays, providing early insight into functional efficacy and cytotoxic thresholds.

Target Validation & Target Engagement

Target Validation & Target Engagement

  • Biochemical (Enzyme/Receptor) Assays
  • Binding Assays
Confirms molecular targets and quantifies compound affinity through enzyme kinetics, receptor binding, and biochemical assays, ensuring precise target modulation and selectivity.

In-Vivo Drug–Drug Interaction (DDI) Confirmation

In-Vivo Drug–Drug Interaction (DDI) Confirmation

Confirms pharmacokinetic or pharmacodynamic interactions identified in-vitro through in-vivo verification, ensuring safety in combination therapies or co-administered regimens.

Dose-Range Finding & Proof-of-Concept Studies

Dose-Range Finding & Proof-of-Concept Studies

Determines safe and effective dosing ranges in animal systems, identifying preliminary efficacy and potential adverse effects to inform first-in-human dose projections.

Efficacy (Disease) Models

Efficacy (Disease) Models

Rodent & Non-Rodent Models (Oncology, Infection, CNS, Cardiovascular, and Metabolic Diseases) Assesses the therapeutic potential of compounds using validated disease models to demonstrate proof-of-concept and mechanism of action before clinical translation.

PK/PD Studies & Modelling

PK/PD Studies & Modelling

  • Dose–Response Studies
  • Exposure–Response Relationships
  • Translational Modelling
Integrates pharmacokinetic and pharmacodynamic data to determine optimal dose ranges, therapeutic indices, and biological efficacy correlations.

Non-Clinical Pharmacokinetic (PK) Studies

Non-Clinical Pharmacokinetic (PK) Studies

  • Single & Multiple Dose Pharmacokinetics
  • Tissue Distribution & Toxicokinetics
Evaluates the systemic exposure, clearance, and bioavailability of drug candidates through validated PK protocols, helping establish dose proportionality and safety margins.

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