Customized solutions to meet unique pediatric program needs

Pediatric formulation development

Our scientists have considerable experience in developing palatable formulations in the OTC/consumer health care industry and have successfully developed customized pediatric pharmaceutical formulations which have received regulatory approval.

Taste masking

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.

Taste assessment and PK studies

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.

Global patient clinical supplies 

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.

Commercial manufacture 

Our production facilities in Philadelphia are fully inspected and approved by FDA, EMA, PMDA and DEA and specialize in low volume products.

PIP/PSP regulatory support 

We support regulatory processes for your Pediatric Investigation Plans and Pediatric Study Plans.

When you need flexible solutions for your pediatric drug development programs, Quotient is your answer.