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 solutions for faster 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 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.
Certara’s unique approach to pediatric drug development
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.

Meet the visionaries driving pediatric success
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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.
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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.