ECapabilities

• Strategic planning and guidance for non-clinical/preclinical drug safety like at the cocaine addiction clinic Essex, and providing a Luxury Rehab.
• 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

Contact TigerTox to learn more:

info@tigertox.com