Certara is transforming pediatric drug development with innovative modeling, simulation, and regulatory strategies. Our unique Pediatric MIDD approach integrates cutting-edge biosimulation with regulatory science, enabling the design of pediatric programs that meet global regulatory standards and ensure safe, effective medicines for children. With over 100 successful pediatric programs in our portfolio, we provide unmatched expertise in addressing challenges such as small populations, research burden, and physiological differences across age groups.
Pediatric Drug Development
Advancing pediatric drug development with Certara
Innovative, evidence-based pharmacometrics, modeling and simulation, and model-informed drug development (MIDD) strategies to accelerate access to life-saving medicines for children.
Learn more about our Pediatric Drug Development Services
Comprehensive pediatric drug development support
Strategic planning
Create robust pediatric study plans (PSPs) and PIPs informed by pharmacometrics and MIDD strategies, ensuring alignment with global regulatory expectations.
Innovative modeling
Leverage pharmacometrics, including population PK, exposure–response (PK/PD), PBPK, and disease progression models, to optimize dosing, support extrapolation, and inform key development decisions.
Regulatory expertise
Navigate complex pediatric regulatory landscapes using pharmacometrics-driven evidence and MIDD strategies to support dose justification, extrapolation, and regulatory interactions.
Comprehensive services
End-to-end support integrating pharmacometrics, MIDD, regulatory strategy, and real-world evidence across the pediatric development lifecycle.
These approaches form the foundation of a MIDD strategy, enabling predictive, evidence-based decision-making across pediatric programs.
Certara’s unique approach to pediatric drug development
Explore our pediatric drug development solutions
Clinical pharmacology
Strategies tailored for pediatric populations.
Pharmacometrics
Enabling pediatric development through advanced pharmacometrics, translating adult data to children, optimizing dosing, and informing efficient, regulatory-aligned trial design.
Juvenile toxicology
Ensuring the safety of pediatric therapies.
Real-world evidence
Data-driven insights from pediatric populations.
Meet the visionaries driving pediatric success
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Experts
Amy Cheung, PhD
Vice President, Certara Drug Development Solutions
Dr. Cheung leads pediatric pharmacometric strategies, with expertise in PK/PD modeling and regulatory planning.
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Experts
Justin Hay, PhD
Senior Director, Clinical Pharmacology and Translational Medicine, Certara Drug Development Solutions
Dr. Hay has over 25 years of clinical pharmacology experience, previously working as a clinical pharmacology assessor of the MHRA (UK) and EMA.
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Experts
Eva Berglund, PhD
Director, Clinical Pharmacology and Regulatory Strategy, Certara Drug Development Solutions
Dr. Berglund has over 12 years of experience working with all types of molecules in marketing applications, clinical trials and scientific advice procedures in the EMA.
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Experts
Trevor Johnson, PhD
Principal Scientist
Dr. Johnson develops cutting-edge pediatric software for dose predictions and drug response analysis.
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View allPartner with Certara for pediatric drug development
Certara is your partner in overcoming pediatric drug development challenges and accelerating access to life-saving medicines for children. With advanced biosimulation tools, regulatory expertise, and a proven team, we deliver solutions that meet and exceed expectations.
Expertise in over 15 therapeutic areas.
Proven track record with more than 100 pediatric programs.
Industry-leading tools like Simcyp™ Pediatric PBPK Simulator.
Contact Certara
Frequently asked questions
What is the RACE for Children Act?
The RACE for Children Act mandates iPSP submissions for oncology drugs targeting pediatric cancers.
How does Certara ensure regulatory compliance?
Certara’s team provides expert guidance on PIP/PSP submissions and regulatory interactions with FDA and EMA.
What tools does Certara use in pediatric drug development?
The Simcyp™ Pediatric PBPK Simulator is a key tool used for modeling and predicting drug performance.
