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Pharmacometrics Consulting

Certara wheel

Strengthen Drug Development and Regulatory Decisions with Quantitative Confidence

Certara’s pharmacometrics consulting team applies population pharmacokinetics (PopPK), pharmacokinetic/pharmacodynamic (PK/PD), and exposure–response (E-R) modeling to support critical development and regulatory decisions.

From early dose selection through New Drug Application (NDA), Biologics License Application (BLA), and Marketing Authorization Application (MAA) submissions, we deliver rigorous, submission-ready pharmacometric analyses that help sponsors move forward with clarity and confidence.

Why Partner with Certara Pharmacometrics

Evidence-Based Dose and Strategy Decisions

Use quantitative modeling to guide dose selection, trial design, and benefit–risk evaluation across development phases.

Regulatory-Ready Analyses

Generate high-quality pharmacometric deliverables aligned with global regulatory expectations.

Integrated Scientific Expertise

Work with experienced pharmacometricians supported by dedicated data programmers to ensure fit-for-purpose datasets and defensible results.

Support for Standard and Expedited Timelines

Access scalable expertise when pharmacometrics sits on the critical path to submission.

Proven Experience

  • 120+ PhD, PharmD, and MD consultants across therapeutic areas
  • Extensive experience supporting global regulatory submissions
  • Integrated modeling approaches spanning PopPK, PK/PD, and exposure–response

Pharmacometrics is not simply a technical requirement, it is a strategic component of modern drug development and regulatory strategy.

What we deliver

  • Population pharmacokinetic (PopPK) modeling
  • Pharmacokinetic/pharmacodynamic (PK/PD) analyses
  • Exposure–response (E-R) modeling
  • Dose optimization strategies
  • Submission-ready reports and regulatory documentation

Our focus is clear: deliver robust quantitative evidence that strengthens development decisions and supports regulatory success.

"Certara provided valuable support in refining dosing strategies and facilitating regulatory discussions for Givinostat. Their contributions helped us navigate the submission process effectively. We appreciate the collaboration and look forward to working together again."

VP, R & D
Italfarmaco

Speak with an Expert

Schedule a consultation to discuss your program, development phase, and submission timelines. Our team will help you define the right pharmacometric strategy for your needs.