Toxicological Evaluation

The goal of toxicological evaluation is to determine the adverse effects of drugs in well-defined biological systems, which have their unique susceptibility to the selected model

→Planning, strategy and designing studies in the appropriate model

→Selection of CROs (GLP/Non-GLP) for the conduct of non-clinical studies.

→Vendor Qualification: Audit of CRO for GLP compliance.

→Drafting or review of study documents like:

1.    Study plans/ protocols.

2.    Study raw data.

3.    Study reports.

→Study monitoring on behalf of Sponsor: a study-based GLP audit.

→Review, interpretation and expert opinion on representation of toxicology data.

→Guidance on finalizing required toxicopathology markers for inclusion in study design.

→Gap analysis and independent data review.

→Scientific analysis of data and conclusions.

→Pre/post-marketing toxicology consulting.