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.
In our webinar series, we cover Pediatric Formulation. These learning materials are designed for a deeper understanding of the underlying techniques and of our latest innovative tools.
Discover how pharmaceutical and biotechnology organisations have achieved success using our Pediatric Formulation and Product Development program.
AAPS 2017 on-stand presentations
Quotient scientists answer your questions surrounding spray drying, formulation optimization, GMP manufacturing and pediatric formulation.
Enabling Clinical Assessment of Maralixibat for Rare Pediatric Liver Disease via Real Time Adaptive GMP Manufacturing - AAPS 2017
A flexible, real-time adaptive GMP manufacturing model is required to support the increasing requirement for clinical trial conduct in small patient populations with challenging trial designs and treatment algorithms.
A feasibility study to assess the acceptability of solid dosage forms in children - EuPFI 2017
Pediatric formulation development is currently a hot topic within the pharmaceutical industry, this poster describes a feasibility study to assess the acceptability of solid dosage forms in children.
Our expertise and capabilities enable us to meet the complex technical challenges of pediatric products and provide you with a unique integrated development solution.