How do I access customized solutions to meet my unique pediatric program needs?
Quotient is your answer.
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.
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.
Our production facilities in Philadelphia are fully inspected and approved by FDA, EMA, PDMA 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 programs, Quotient is your answer.
Accelerating the development of new medicines for children
Our partnership with Pharmaceutical Product Development LLC (PPD) provides an innovative solution that offers industry-leading end-to-end support for all stages of pediatric drug development — from chemistry and manufacturing through all clinical trial phases, and on to commercial manufacturing.
- Accelerated timelines, reduction of costs and easing of regulatory burden
- A single solution for an entire pediatric program, with only one contract and one point of contact
- Rapid development and clinical testing of pediatric formulations
- Comprehensive program design and regulatory support
- Combined global expertise in formulation, manufacture and clinical development of pediatric medicines
Partnering to accelerate pediatric drug development
Through our partnership with PPD, we can provide one solution to execute an entire pediatric program with the potential for one contract and a single point of contact.
Challenges and Opportunities in Pediatric Product Development
Over the last decade global regulatory bodies have increased the pressure on industry to develop authorized medicines for pediatric populations in order to improve and protect child health.