Services

Assessing Current State of Development

Optimizing Nonclinical and Clinical Development Approach

Optimizing Nonclinical and Clinical Development Approach

• Review of bioanalytical method validations and suitability
•  Due diligence assessments and lead compound selection
• Nonclinical or clinical PKPD development gap analysis 
• Evaluation of the clinical implications of nonclinical PKPD results 

Optimizing Nonclinical and Clinical Development Approach

Optimizing Nonclinical and Clinical Development Approach

Optimizing Nonclinical and Clinical Development Approach

• PKPD aspects of clinical development plan preparation and study design 
• Clinical synopsis and protocol preparation or review  
• Assessing the impact of clinical results on subsequent clinical study designs and sequencing 

Evaluating Regulatory Readiness

Optimizing Nonclinical and Clinical Development Approach

Evaluating Regulatory Readiness

• Nonclinical or clinical PKPD regulatory gap analysis 
• Regulatory summarization
• Regulatory staging and transition
• Product Labeling support