Assessing Current State of Development


  • 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


  • 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


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