Derivation of Safe limit for drug impurities

Derivation of Safe limit for drug impurities

Health Based Exposure Limit (HBEL) OEL and PDE/ADE

QSAR modelling (statistical and rule based) for mutagenicity Assessment

Toxicology

General Toxicity studiesAcute toxicity studies in Rats and mice, MTD studies in rat and mice with TK, Dose escalation and range-finding, Non-GLP 4, 7 and 14 day toxicity studies in rat and mice with TK, Sub-chronic & Chronic GLP Toxicity studies Genotoxicity studiesAmes test, Chromosomal Aberration test (in vitro & in vivo), Micronucleus test (in […]

Drug Metabolism and Pharmacokinetics(DMPK )

Bio analytical method development and validation Metabolite identification PK and TK in rodent/non-rodents Plasma protein binding Metabolic stability Permeability studies Assessment of physicochemical & in vitro ADME properties PK/PD

Pharmacology ( In Vivo & In Vitro )

Therapeutic areas :- Inflammation, Dermatology, Metabolic disorders, Cardiovascular, CNS, Immunomodulation, Oncology

Medical Devices

Biocompatibility :- Cytotoxicity, Skin Sensitization, Irritation, Pyrogen, Hemo-compatibility & Implantation tests.

Biocides

Biocide development, Toxicological and Genetic toxicology and the effectiveness of the Active ingredient.

Risk Assessment

Response to Queries from Regulatory Agencies (Toxicology related) Preparation of Safety Data Sheet (SDS) for chemical, API and finished products Derivation of F (failure) value for Determining Child-Resistant Packaging of pharmaceutical product Preparation of Non-clinical Overview and Non-Clinical Summary of pharmaceutical product Prescribing Information-Pregnancy Lactation and labelling Rule (PLLR)

Endocrine disruptors

Endocrine Disruptors, chemicals that can interfere with the endocrine system, are known to cause multiple reproduction and development related adverse effects in both human and wildlife. We have expertise in the development of advanced scientific methods using innovative screening technologies to evaluate these chemicals for potential endocrine disruption. Tier 1: A general screen identifying interaction […]