Solutions to address challenges due to a lack of specific ICH guidelines

Proposal of an optimal GLP study package

A document-based evaluation,​ based on data collected during the exploratory phase, is conducted, and a GLP toxicology study package that meets the client’s objectives (IND application, etc.) ​is proposed. AXCELEAD experts, with experience in INDs for over 100 products, provide support in overall study management, interpretation of safety margin, and resolution of toxicity issues.
navigate_next Total support for non-clinical safety assessment

For example, our services can be used in the following situations: