• Strategic planning and guidance for non-clinical/preclinical drug safety
  • Identification of global strategies to optimize preclinical development timelines and commercial value
  • Non-clinical drug safety development plan preparation (lead identification through Phase IV)
  • Interaction with Discovery /Lead Development Teams to incorporate/interpret toxicological endpoints
  • Range-finding, Preclinical, and Clinical–stage toxicology studies
  • Providing toxicology services to venture capitalists and start-up companies
  • Preparation or review of Clinical Investigator Brochures
  • Customized design, analysis, and management of non-clinical safety assessment protocols, studies (GLP and non-GLP, including specialty studies), and programs
  • Toxicology data analysis, interpretation, and report preparation
  • Editing and/or review of toxicology study reports
  • Non-clinical program management support/participation/leadership for drug development teams
  • Team meeting facilitation 
  • Management of team communications 
  • Due-diligence reviews for licensing candidates
  • Selection of GLP/non-GLP contract research organizations and study placement
  • Monitoring of study conduct
  •  Liaison with and project management of CROs (i.e., coordinate and monitor individual studies and standardize results to ensure efficient timelines)
  • Evaluation/resolution of unexpected scientific, product safety, and regulatory issues
  • Project management
  • Assessment of preclinical risk/safety profile
  • Preparation of integrated study summaries and CTD tables
  • Preparation or editing of toxicology submissions for FDA and international regulatory agencies
  • Literature reviews and expert reports/white papers
  • Preparation, review, and/or editing of critical reviews and manuscripts for publication
  • Preparation, review, and/or editing of position papers in response to regulatory queries
  • Developing or reviewing presentation materials for external meetings
  • Special expertise in neurotoxicology
  • Advise on and preparation of responses to global regulatory queries
  • Attending scientific or regulatory meetings and preparing detailed, customized reports
  • Participating with client in regulatory interactions
  • Drafting or updating toxicological section of MSDS form
  • Resolving impurity and degradant/metabolite issues and qualifications
  • Acting as a liaison between academic institutions and pharmaceutical companies (e.g., establish beneficial partnerships with academic institutions for drug-specific investigative studies)
  • Providing staffing help during periods of overload (on-site or virtual)
  • Interim or long-term management of toxicology studies/programs
  • Evaluating and interviewing for toxicology staff positions
  • Peer review
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