White Paper

Strategies for Accelerating the Development of Modified Release Oral Forms

Pediatric Drug Development

How do I access customized solutions to meet my unique pediatric program needs?

Quotient Sciences has extensive knowledge and capabilities that enable us to provide you with a unique integrated pediatric development solution.

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Pediatric formulation and product development

The development of acceptable, palatable pediatric formulations is a key feature within the industry today, driven by patient needs and regulatory requirements. Quotient Sciences has extensive knowledge and capabilities that enable us to provide you with a unique integrated pediatric development solution.

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.

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.

Benefit from:

  • 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

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