Pharmacometrics
Services

Pharmacometrics that drive regulatory success

Certara supported over 20 drug approvals in 2024 through strategic, data-driven pharmacometric modeling, model-based analyses, and clinical pharmacometrics consulting services. Whether you’re preparing for submission or making key go/no-go decisions, our expert team helps you overcome complexity, meet tight timelines, and align with regulatory expectations. 

Why leading teams choose Certara

Proven quantitative & regulatory expertise

We deliver pharmacometrics strategies and analyses aligned with current global regulatory requirements—ensuring your submission is fit-for-purpose and submission-ready.

End-to-end support for high-stakes decisions

Through PK-PD modeling, PK analysis, population pharmacokinetics, exposure-response analysis, dose simulations, and model-based meta-analysis (MBMA), we provide the insights needed to answer critical questions: 

  • What is the optimal dose and regimen?
  • What patient factors influence safety and efficacy?
  • Are dose adjustments needed based on intrinsic/extrinsic factors?
  • How does our asset compare to standard of care? 
  • Will this treatment deliver meaningful long-term outcomes?
  • Should we proceed with development? (Go/No-Go) 

Predictive insights through Model-Based Meta-Analysis

Certara’s MBMA services synthesize data across trials to: 

  • Benchmark your asset against standard of care
  • Predict long-term efficacy and safety outcomes
  • Support payer, HTA, and regulatory engagement with robust comparative data 

Accelerated, scalable delivery

Facing short timelines or complex, heterogeneous data? We’re built for that. Our cross-functional teamfeaturing expert pharmacometricans, clinical pharmacologists, regulatory writers, statisticians, and programmers—streamline delivery from early development through submission.

"Partnering with Certara’s pharmacometrics team was a game changer for our development program. Their modeling expertise gave us the clarity and confidence we needed to select the optimal dose and design a streamlined clinical strategy. Thanks to their support, we avoided an additional Phase 2 trial and accelerated our regulatory submission timeline."

— VP, Clinical Development, Mid-Size Biotech Company

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About Certara

Certara is dedicated to transforming drug discovery and development for good. We harness the power of biosimulation, advanced analytics, and regulatory expertise to create a future where treatments reach patients faster and more efficiently.

From discovery to market access and commercial, we tailor solutions to meet our clients’ most pressing challenges. Through strategic leadership and advanced predictive technologies, Certara provides comprehensive solutions to optimize drug development processes, reduce risks, and improve outcomes. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.

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