Adgyl Lifesciences Pvt. Ltd.

In vitro chromosomal aberration test using human peripheral blood lymphocytes.

GLP-compliant in vitro assay for detecting structural chromosome aberrations.

In vitro chromosomal aberration test using human peripheral blood lymphocytes.

GLP-compliant toxicity study to determine maximum tolerated dose in rodents or non-rodents.

MTD and 10-day repeat dose range finding study in rats.

MTD and 10-day repeat dose range finding study in dogs.

Drug Metabolism and PharmacoKinetics services offered to support lead optimization and preclinical development, including in vitro assays, in vivo PK study analysis, and toxicokinetics.

Preclinical discovery DMPK support including in vitro CYP inhibition, protein binding assays, and pharmacokinetic screening cascades for active lead optimization programs.

Sub-chronic repeat dose toxicology evaluation in mice and rats including toxicokinetic analyses.

Sub-chronic repeat dose toxicology testing in non-rodent species with toxicokinetics.

GLP-compliant neurobehavioral evaluation in rats.

GLP-compliant neurobehavioral evaluation in rats.

Neurological and behavioral evaluations in rats.

Assessment of fertility and early embryonic development parameters in rodent species.

SEG-I fertility and early embryonic development studies in mice and rats.

GLP repeat-dose toxicology studies including MTD, dose range finding, and 28-day repeat dose toxicity studies in rats and dogs.

Comprehensive bioanalytical services including small molecule bioanalysis, large molecule bioanalysis, and elemental analysis using ICPMS to support preclinical and clinical trial studies.

GLP-compliant and non-GLP safety assessment and toxicology testing services for IND-enabling packages.

Comprehensive biocompatibility testing services for medical devices to establish safety and support regulatory approvals as per ISO 10993 standards and GLP compliance.

Comprehensive ADME services to evaluate absorption, distribution, metabolism, and excretion for preclinical drug candidates.

GLP-compliant genotoxicity testing including the Ames test, in vitro chromosomal aberration test, and micronucleus test.

Adgyl Lifesciences provides GLP and non-GLP pharmacology and efficacy studies using in vitro and in vivo models to efficiently support drug development and regulatory submissions.

End-to-end testing services providing integrated biocompatibility and safety assessment to meet global regulatory requirements and support market access.

GLP safety pharmacology assessments covering hERG assays, modified Irwin tests, functional observation battery, and cardiovascular/pulmonary functions.

In vitro safety and compliance testing for cosmetics and consumer products aligned with 3R and ECVAM guidelines.

Preclinical and clinical trial bioanalysis services offering validated and regulatory-ready data.

Short-term dose range finding study in mice or rats for preclinical evaluation.

GLP-compliant in vivo assay using mice or rats to evaluate chromosomal damage.

Custom medicinal chemistry services to support drug discovery and development programs for small molecules and biologics.

GLP-compliant dose range finding study in rodent and non-rodent species.

GLP-compliant genotoxicity assay to evaluate mutagenic potential.

Comprehensive testing services designed for regulatory approval on herbals, nutraceuticals, food ingredients, color additives, and novel foods complying with FDA and EFSA requirements.

In vivo micronucleus assay conducted in rodent models to evaluate genetic effects under whole-organism exposure.

Definitive study to evaluate embryo-fetal development and teratogenicity.

Bacterial reverse mutation test utilizing Salmonella typhimurium and E.coli strains to identify substances that cause mutations.

Process chemistry services for preclinical and early clinical development.

GLP-compliant safety pharmacology assay to evaluate cardiac ion channel activity.

In vitro mammalian cell micronucleus test using Human Peripheral Blood Lymphocytes.

Cytotoxicity evaluation assays including elution, agarose overlay assay, direct contact assay, MTT assay, and NRU assay for biomedical devices.

In vitro mammalian chromosomal aberration test using CHO-K1 and Human Peripheral Blood Lymphocytes.

In vitro assays including Ames, CHAB, and TK/ML assays tailored specifically for biomedical devices.

In vivo or in vitro micronucleus test in rodents.

Exploratory telemetry study in dogs for screening toxicology.

In vitro mammalian cell gene mutation tests using L5178Y TK+/- -3.7.2C and TK6 cells.

Preliminary toxicity study assessing embryo-fetal development in multiple species.

Dedicated male and female fertility and early embryonic development assessment.

Long-term repeat dose toxicology studies in non-rodent species including Beagle dogs, minipigs, and NHP with toxicokinetics.

Non-GLP exploratory safety and screening studies including Mini Ames, Mini hERG, dose range finding, and CVS function screening.

Juvenile toxicity studies designed to support pediatric development programs in accordance with ICH S11 guidelines.

Extended repeat dose toxicology studies in rodent models with integrated toxicokinetic evaluations.

Prenatal developmental toxicity testing across multiple appropriate species.

Quantification of clinical trial samples for analytes and/or metabolite for Phase I through Phase II Studies, featuring method development and validation for NCEs and generics.

In vitro mammalian cell gene mutation assay using CHO-K1 cell line.

Reliable, human-relevant safety assessment services using validated alternative methods including OECD-aligned models for skin and eye irritation, endocrine disruption, and phototoxicity.

Cardiovascular function assessment using telemetry in dogs under GLP conditions.

GLP-compliant safety pharmacology assessment in rats.

Evaluation of pre- and postnatal development including maternal function and offspring growth.

Comprehensive immunological endpoint assessments conducted concomitantly with routine toxicity studies to evaluate potential effects on the immune system.

Perinatal toxicity study to evaluate late gestation and lactation effects.

Non-GMP and cGMP synthesis and manufacturing services for small molecule drug substances across early and late clinical development.

Carcinogenicity studies conducted in mice and rats as part of non-clinical safety evaluation for NDA filing.

Embryo fetal development toxicity studies conducted across multiple species including mice, rats, and rabbits.

In vivo imaging facility services to support preclinical testing.

Short-term carcinogenicity study using transgenic rasH2 mice inclusive of toxicokinetic evaluations.

In vitro biology services for drug discovery and development.

Customizable testing package to test antidiabetic drugs for Beta cell proliferation as per regulatory guidelines for product development and regulatory submissions.

End-to-end support from early target evaluation through lead optimisation and IND-enabling readiness, offering medicinal chemistry, synthetic chemistry, and analytical services.

Short-duration repeat-dose toxicity studies and single-dose studies in rodents and non-rodents.

Comprehensive portfolio of toxicology studies designed to support New Drug Application (NDA) submissions with scientifically robust and cost-effective safety data.

Pulmonary function testing in rats to evaluate respiratory safety.

Well-controlled inhalation toxicity studies designed to evaluate systemic and local respiratory effects using nose-only exposure systems.

An in vitro test used to study the effect of a drug substance or biomaterial on the coagulation cascade pathway by checking how well platelets clump together to form blood clots.

In vitro mini hERG assays for targeted safety pharmacology.

Integrated toxicological and ecotoxicological studies supporting safe agricultural innovation, including genetic toxicology, in vitro assessments, acute studies, repeated dose investigations, developmental and reproductive toxicity, endocrine disruption, neurotoxicity, chronic/carcinogenicity/oncogenicity, metabolism studies, and ecotoxicology.

Pre-natal and post-natal development toxicity studies (SEG-III) in rats.

Customizable testing packages to assess potential cytotoxic effects arising from the interaction of contact lenses with contact lens care solutions according to ISO 18189.