The development of acceptable, palatable pediatric formulations is a key feature within industry today, driven by patient needs and regulatory requirements.
Our scientists have considerable experience of developing palatable formulations in the OTC/consumer healthcare industry which has been successfully applied to develop customized pediatric pharmaceutical formulations.
We have an extensive track record of developing age-appropriate dosage forms of aversive, bitter drug substances using a range of taste-modifying and taste-masking techniques without compromising on product stability and pharmacokinetic performance.
Using our integrated GMP manufacturing and clinical testing platform we perform rapid, adaptive trials in humans to optimize taste attributes and/or PK performance to ensure clinical validation prior to proceeding to pivotal pediatric trials.
We manufacture, package, release and supply GMP drug products ready for dosing on a worldwide basis, in line with study and recruitment needs. Flexibility is key, ranging from a personalized, per-patient basis or via more traditional batch manufacturing.
Our production facilities in Philadelphia are fully inspected and approved by FDA, EMA, PDMA and DEA and specialize in low volume products.
We can support regulatory processes for Pediatric Investigation Plans and Pediatric Study Plans.