Pediatric Center of Excellence
Our out-sourced “Pediatric Center of Excellence” model is a unique resource of pediatricians, pharmacometricians, regulatory, juvenile toxicology and formulation scientists that develop pediatric drugs through all stages of development.
Our pharmaceutical industry seasoned teams bring expertise and insight to help you effectively navigate the complex pediatric regulatory environments in the US and Europe
All aspects of pediatric product development
With our partners we design, manage and conduct all aspects of pediatric product development including:
- Age appropriate formulations
- Juvenile toxicology studies
- Dose extrapolation
- PK/PD modeling and simulation
- Physiologically Based Pharmacokinetic (PBPK) Modeling
- Population PK/sparse sampling strategies
- PIP and PDP applications
- Global clinical trials & regulatory submissions
We are dedicated to one single goal namely “Bringing better medicines to children”
Contact us with any questions you may have about our company or our services.