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Pharmacometrics Services

Optimize drug development and regulatory decisions

Available for both standard and expedited timelines for NDA, BLA, and MAA submissions

Advancing drug development with Certara Pharmacometrics Services

Pharmacometrics integrates knowledge of drug exposure and response to support dose selection, safety, and efficacy. Our global team applies advanced population pharmacokinetic (PopPK), pharmacokinetic-pharmacodynamic (PK/PD), and exposure–response modeling to inform development decisions and accelerate clinical programs.

We deliver the full range of pharmacometrics analyses required for regulatory submissions, helping sponsors optimize trial design, support dose justification, and generate evidence across diverse patient populations, including special populations, such as pediatric and rare disease patients. These approaches are increasingly central to model-informed drug development (MIDD) and evolving regulatory frameworks such as ICH M15.

Our Pharmacometrics capabilities

Data-driven development decisions

Apply quantitative modeling frameworks to inform dose selection, evaluate variability in drug response, and support confident development decisions.

Optimized clinical trial design

Leverage pharmacometrics modeling to design more efficient studies and evaluate dosing strategies to improve likelihood of success.

Special populations expertise

Support dosing and development strategies for complex populations, including pediatric, rare disease, and organ impairment populations.

Regulatory-ready pharmacometrics analysis

Deliver high-quality PopPK, PK/PD, and exposure–response analyses aligned with regulatory expectations, including MIDD and ICH M15.

Pharmacometrics for special populations

Many development programs must address populations that are difficult to study through traditional trials. Pharmacometrics enables sponsors to integrate available data and generate quantitative evidence to inform dosing and treatment strategies.

Modeling approaches are particularly valuable for:

  1. Pediatric populations
  2. Rare disease populations
  3. Patients with renal or hepatic impairment
  4. Geriatric populations
  5. Pregnant or lactating patients

These models integrate diverse data sources to evaluate exposure, predict variability, and support regulatory decision-making.

Combining world class pharmacometricians and technology for superior drug development insights

Our pharmacometrics team designs and implements MIDD strategies across therapeutic areas, drug modalities, and development phases. We support programs for diverse populations, including pediatric and rare disease patients, while delivering analyses that are fully aligned with regulatory expectations and ready for submission across both standard and accelerated timelines.

Largest network of global experts

With over 120+ PhD, PharmD, and MD consultants, Certara provides unmatched expertise across therapeutic areas and development phases.

Proven Regulatory Succes

Over 90% of novel drugs approved by the US FDA have used Certara’s software and services.

High-quality datasets

Certara data programmers ensure datasets are ready for fit-for-purpose PK and PK/PD modeling.

The ICH M15 is finalized. Is your MIDD strategy aligned?

The ICH M15 guideline harmonizes global expectations for model-informed drug development. From early planning and Model Analysis Plans to submission-ready documentation, sponsors must demonstrate structured, credible modeling strategies.

Explore our expert resources below and connect with our Pharmacometrics team to ensure your approach aligns with the new framework.

Why Certara?

Certara is the leading provider of pharmacometrics services, combining expertise, innovation, and robust methodologies to deliver regulatory-compliant solutions that optimize drug development decisions. Our team’s experience spans all stages of drug development, ensuring precise, data-driven insights and maximum commercial success.

120
Pharmacometrics consultants over five continents
800
Pharmacometrics projects completed in the last four years

Partner with Certara to leverage the world’s most experienced pharmacometrics team. Our experts are dedicated to delivering innovative, regulatory-compliant solutions that optimize drug development outcomes.

Access a team of 120+ pharmacometricians with proven expertise.
Utilize high-quality datasets and advanced quantitative methods.
Maximize success with data-driven decisions at every stage.

Speak with an expert


FAQs

What is pharmacometrics?

Pharmacometrics uses mathematical modeling to quantify drug-patient interactions, supporting regulatory decisions and optimizing drug development.

How does Certara support regulatory submissions?

Certara provides regulatory-compliant PK/PD analyses and modeling to ensure successful submission packages.

What phases of drug development does Certara support?

Certara supports all phases, including preclinical, early clinical, and late clinical development.