Our Services
Basic Service
Foundational Consulting & Safety Reviews
Including, but not limited to:
• Target Knowledge Reviews (TKR)
• Literature and database research for early risk identification
• Preliminary safety strategy for target/compound selection
• Overview of study design recommendations
💡 Ideal for early-stage biotech companies seeking foundational safety insight to inform discovery and development decisions.
Intermediate Service
Preclinical Study Design & Specialty Safety Assessments
Including, but not limited to:
• Design and interpretation of non-clinical (in vivo) toxicology studies across multiple durations (2-week, 4-week, 3-month, 6-month, etc.)
• Clinical and histopathology assessments and pathology peer reviews
• Assessment of genotoxicity, immunotoxicity, developmental and reproductive toxicity, cardiovascular toxicity, neurologic alterations, abuse potential, renal toxicity, and respiratory toxicity.
• Design and interpretation of investigative pathology models and conduct of Pathology peer reviews on exploratory and GLP studies
💡 Ideal for enabling successful clinical development through tailored risk management strategies, strategic regulatory guidance, and data-driven safety analysis.
Advanced Service
Regulatory Strategy, Risk Management & Data Science Integration
Including, but not limited to:
• Development of custom risk management strategies using public data and mechanistic CRO studies, with results translated into communications for project teams and health authorities
• Regulatory document creation: white papers, issue management plans, response letters
• Asset team support from IND through registration and post-marketing
• Application of data analysis and algorithm development to enhance safety and pathology risk management
💡 Ideal for clients facing complex or high-stakes safety and regulatory challenges that require senior-level expertise.
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