Our scientists have considerable experience in developing palatable formulations in the OTC/consumer health care industry. We have developed customized pediatric pharmaceutical formulations that have received regulatory approval.
We have an extensive track record 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 PK performance.
Using our integrated GMP manufacturing and clinical testing platform, we perform rapid, adaptive trials in humans to optimize taste attributes and PK performance. This provides you with the clinical validation that you need prior to proceeding to your pediatric trials.
We manufacture, package, release and supply GMP drug products ready for dosing on a worldwide basis, in line with your study and recruitment needs. Our flexible options range from a personalized, per-patient basis to more traditional batch manufacturing.
Our production facilities in Philadelphia, PA are fully inspected and approved by FDA, EMA, PMDA and DEA and specialize in low volume products. We support regulatory processes for your pediatric investigation plans and pediatric study plans.