Pharmaceutical/Dietary Supplements/Medical Devices
Evaluate nonclinical data for Investigational Device Exemptions (IDE).
Conduct pre-study audits of toxicology and bioanalytical testing facilities to ensure compliance for Sponsor studies.
Quality assurance review of study design to ensure compliance with FDA Quality System (QS) regulations.
Evaluate the safety of dietary supplements.
Literature review and analysis of toxicology and pharmacokinetic studies to develop occupational exposure limits (OEL).