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