Kandih Bioscience

Kandih Bioscience is a toxicology consulting firm specializing in regulatory support for pharmaceutical, biologic, and combination product development. The company provides nonclinical services spanning regulatory strategy, documentation preparation, and study execution support.

The firm's core capabilities include preparing IND and NDA submissions in Common Technical Document format, conducting toxicology risk assessments for medical device extractables and leachables, designing and monitoring nonclinical studies at contract research organizations, and supporting regulatory agency interactions. Their multidisciplinary team handles pharmacokinetics, ADME studies, genetic toxicology, and safety pharmacology programs.

Kandih positions itself as a small, flexible consulting operation that brings together expertise from multiple scientific disciplines. The company also features a ToxWiki tool for drug interaction analysis accessible to patients, physicians, and researchers.

Consider Kandih Bioscience when you need specialized toxicology consulting for regulatory submissions and your project requires deep expertise in nonclinical safety assessment. The firm's small size may provide more personalized service and direct access to senior consultants compared to larger CROs.

Expect support across the regulatory preparation process, from gap analysis of existing development plans through preparation of regulatory documents and study monitoring. The company's focus on toxicology makes them most valuable for projects where safety assessment and risk characterization are critical components.

Kandih Bioscience operates exclusively in the healthcare sector, providing toxicology and regulatory consulting services for pharmaceutical and medical device companies. Their work focuses on ensuring products meet FDA, EMA, and Health Canada safety requirements before human testing.

The company demonstrates healthcare specialization through expertise in IND/NDA submissions, medical device biocompatibility assessments, and nonclinical safety studies required for regulatory approval. Their ToxWiki tool also extends their healthcare focus to patient and physician education around drug interactions and medication safety.

The ideal client is a pharmaceutical, biotechnology, or medical device company in the preclinical or early clinical stages of product development requiring toxicology expertise for regulatory submissions. Companies developing combination products or devices requiring extractables and leachables assessment would particularly benefit from Kandih's specialized capabilities.