Acute and Subacute Toxicity, Repeat Dose Toxicity, Chronic/Subchronic, Developmental and Reproductive Toxicity, Inhalation Toxicity, Genetic Toxicity, Ocular Toxicity, Carcinogenicity, Neurotoxicity, Pharmacokinetic and Tissue Distribution studies.
Impurity Qualification studies, Synthesis and characterisation of impurities including Nitrosamines, Bridging Studies for 505(b)(2) pathway.
Including lead optimization, clinical candidate selection, and regulatory GLP toxicity studies (in vitro and in vivo - rodent & non-rodent) along with the synthesis of the test item.
Include both Phase 1 (Initial Screening of a potential PIE (Pharmaceutical in Environment)) and Phase II (Detailed studies comprising of either Tier A and Tier B scope of studies).
In vitro cell-based bioassays, potency assays, immunogenicity assessment (ADA), surface marker analysis, CD4+/CD8+ ratios, custom HCP assay development, Bulk generation of Monoclonal and Polyclonal Antibodies (Sheep, Goats, Rabbits, Mice, and Rats), Hyperimmune sera, etc.
Lead Optimization, Process Development, Analytical Characterization, Focused Library Synthesis, Custom Synthesis & Supply of Advanced Intermediates, NCEs, Reference Standards, Linkers, Impurities & Metabolites and Small-Scale Synthesis (up to 10kg, Non-GMP).
We specialize in the development and validation of methods for formulation analysis, ensuring the accuracy of dose formulations. Additionally, we provide bioanalytical TK services to assess the analyte of interest in plasma and various other biological matrices. Also, perform bioequivalence assessments for complex injectables where several tissue matrices (~10-14) need to be examined for comparative TK profiling.
Water Solubility, Partition Co-efficient, Vapour Pressure, Density, Surface Tension, Oxidizing Properties, Explosive Properties, Viscosity, Storage Stability under different conditions, Analytical methods (AI content, Development & validations) & 5 batch Analysis.
Acute 6 Pack Studies, In vitro Skin/Eye (Irritation/ Corrosion), Genotoxicity (Ames, Micronucleus, Chromab & Comet assay), Repeated dose (28, 90 and 180 days), Developmental and Reproductive Toxicology (DART), Generational studies with endocrine disruptors assessment, Neurotoxicity & Carcinogenicity.
Short and long-term toxicity in multiple biotic organisms like Alga, Daphnia, Avian, Fish, Earthworm, Chironomus, and Honeybees.
Hydrolysis, Biodegradability, Residue and Adsorption-desorption, Vegetative vigor, Seedling emergence.