Services

Assessing Current State of Development

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  • 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

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  • 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

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