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Pediatric Drug Development

Advancing pediatric drug development with Certara

Innovative, evidence-based solutions for faster access to life-saving medicines for children.

Comprehensive pediatric drug development support

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.

Strategic planning

Create robust pediatric study plans (PSPs) and pediatric investigation plans (PIPs) tailored to regulatory requirements.

Innovative modeling

Leverage PK, PD, and disease progression models to optimize dosing and efficacy.

Regulatory expertise

Navigate complex pediatric regulatory landscapes with expert guidance.

Comprehensive services

End-to-end support, from juvenile toxicology to real-world evidence integration.

Explore our pediatric drug development solutions

Clinical pharmacology

Strategies tailored for pediatric populations.

Pharmacometrics

Quantitative insights for informed pediatric trial designs.

Regulatory affairs consulting

Expert guidance for PIP and PSP submissions.

Juvenile toxicology

Ensuring the safety of pediatric therapies.

Real-world evidence

Data-driven insights from pediatric populations.

Why choose Certara for pediatric drug development?

Certara is a trusted partner in pediatric drug development, offering unparalleled expertise, cutting-edge tools, and a proven track record of success. Our integrated solutions ensure efficiency, compliance, and optimal outcomes, bringing critical pediatric therapies to market faster.

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Partner 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.

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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.