Model smarter. Fail less. Approve faster.

Quantitative modeling is no longer optional – FDA and EMA expect it. The right pharmacometric strategy reduces clinical trial risk, optimizes dose selection, and builds the quantitative evidence base that regulators need to say yes. PLG’s Pharmacometrics & Clinical Pharmacology team delivers model-informed drug development strategies that are regulatory-grade, reproducible, and integrated with your clinical and regulatory teams. 

What we deliver

  • Non-compartmental analysis (NCA) and population PK/PD modeling 
  • Exposure-response modeling for efficacy and safety 
  • First-in-human dose justification and Phase 2/3 trial simulations 
  • PBPK modeling for special populations, drug-drug interactions, and pediatric extrapolation 
  • TMDD modeling for biologics and large molecule programs 
  • Model-based meta-analysis and comparator evidence synthesis 
  • Module 2.7.2 authoring and complete regulatory-ready quantitative reports 
  • Pivotal trial simulations for Phase 3 

Where we outperform

  • Platform-agnostic 
  • Outputs are fully reproducible and submission-ready to IND, protocol, and NDA/BLA deadlines 
  • Integrated with CMC, regulatory, and clinical teams — not siloed 
  • Senior pharmacometricians, not junior analysts, lead every engagement