Pharmaceutical Nonclinical Safety and Medical Devices

ToxStrategies’ Pharmaceutical Nonclinical Safety & Medical Device experts provide strategies across the drug development pipeline from pre-clinical toxicology and safety evaluation through the challenges associated with gaining marketing approvals. Our core services are nonclinical strategy and regulatory support, including strategy development, facilitating regulatory meetings and guiding responses with health agencies around the world, toxicology study design, monitoring and oversight, and preparation of nonclinical regulatory submissions for safety and risk assessment.

Our highly experienced expert toxicologists provide data-driven risk assessment and modeling to deliver smarter, earlier decision making through risk-informed assessments and advanced predictive tools.

• Prepare carcinogenicity and reproductive toxicity assessments
• Develop monographs for excipients and impurities
• Assess metabolite safety to meet regulatory thresholds
• Use QSAR models including Derek Nexus and Leadscop
• Justify waivers and streamline regulatory submissions with data-backed evidence

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Capabilities and Expertise: