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| Name and Educational Degree: |
2 Drylaw Crescent Edinburgh, Scotland EH4 2AU
UK |
| Acting independently on behalf of the customer and offering: • Study design including amendments to standard (ICH/OECD/EPA guideline) designs based on expected pharmacological/class-based considerations or to follow up previous equivocal findings • Study monitoring to ensure compliance with GLP and early availability of interim findings and allowing adaption of pre-clinical programme if findings so require • Data review and interpretation, including a detailed understanding of procedures, and their inherent limitations, permitting expert insight into the validity, strength and accuracy of the conclusions • Report writing when in-house staff are unavailable • Critical peer review of reports • Expert overview of toxicology results from multiple studies to produce an informed overall summary • Selection of suitable laboratories for study placement • Consideration of endocrine vs non-endocrine reproductive findings • Chemical Safety Reports for REACH registration • Chemical classification under Directive 67/548/EEC (now Global Harmonized System (GHS) and critical to REACH). Experienced with distinguishing maternally toxic, vs developmentally toxic dose levels |
| More than 30 years experience in the design and interpretation of preclinical toxicology studies. Familiar with United Kingdom and European guidelines and regulations for registration of pharmaceuticals and chemicals. |
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