Safety Assessment

Comprehensive, GLP-compliant services to support discovery programs, IND, NDA and BLA filings with FDA, EMA and NMPA

Two scientists wearing blue protective suits, masks, and safety glasses work inside a sterile lab environment. Focused on tasks at a laminar flow hood, they ensure a contaminant-free workspace essential for accurate Radiolabelled ADME studies.

Pharmaron’s experienced safety assessment team comprehensively evaluates the safety of new therapeutic candidates and medical devices. Our safety assessment services include general toxicology, safety pharmacology, genetic toxicology, DART through to immunotoxicity and immunogenicity in support of our partner’s IND, NDA, BLA, 510k and PMA submissions worldwide. The different test articles include small molecules, biologics and cell and gene therapy products and medical devices. Due to the significant diversity of test articles, each study design is tailored to the test system’s characteristics, intended clinical applications and regulatory guidelines. Pharmaron’s safety assessment facilities are AAALAC-accredited and have been successfully inspected by worldwide regulatory authorities, including the US FDA, OECD and China NMPA.