KANDIH GROUP LC
Summary
DABT, Toxicology, Quality Assurance, Regulatory Intelligence, Due diligence, Literature Review, Regulatory Training, Quality Training, Toxicology risk assessment, environmental risk assessment, study monitoring, GLP, GCP, GMP, Genotoxicity, Carcinogenicity, Extractables and leachables (E&L) testing, Biocompatibility
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Description
Kandih provides comprehensive professional support services centered on toxicology and regulatory compliance. Our team of expert regulatory toxicologists and clinical specialists meticulously oversee nonclinical and clinical studies conducted at Contract Research Organizations (CROs) to ensure strict adherence to Good Experimental Practice (GxP) guidelines. We excel in conducting in-depth regulatory intelligence, gap analysis, and due diligence assessments for clients undergoing mergers and acquisitions. Our combined expertise in toxicology and regulatory affairs empowers us to deliver precise environmental risk assessments, calculate permissible exposure limits, and conduct thorough literature reviews to substantiate weight of evidence for carcinogenicity studies. Kandih is adept at crafting compelling regulatory submission documents and navigating the complex landscape of global regulatory interactions.
