Impurity qualification
Other toxicology expertise include qualification of impurities, residual solvents or E&L in new Drug Substances and Drug Products according to ICH Q3A(R2), Q3B(R2), Q3C(R9) and Q3D(R2) guidelines. It can include permitted daily exposure determination based on data available and/or literature.
Target safety assessment - Bibliographic review
Patrick assists clients in developing robust strategies, including their target safety assessment, risk assessment, and regulatory pathways, enabling informed decisions as they advance.
Due diligence
Patrick provides evaluation of the nonclinical data available for any given due diligence.
