Orphan drug development for rare diseases

Accelerate your orphan drug development for rare diseases

Accelerating orphan drug development from candidate selection to commercial manufacture and supply

With over 300 million people worldwide living with identified rare diseases, the development of new treatments to address these unmet clinical needs is an area of great interest in the pharmaceutical industry. Despite improvements in regulatory support and commercial rewards for developing orphan drugs, difficulties remain for drug developers in bringing these medicines to market quickly; including limited R&D budgets, alongside an ever-evolving regulatory framework, challenging product development and clinical recruitment.

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Our innovative approach to formulation development integrates drug product development with clinical evaluation, combined with our experience with over 1,000 molecules at all stages of drug developmen

Integrated capabilities and expertise

At Quotient Sciences we have supported over 50 development programs for rare diseases in the past 5 years. Our extensive formulation know-how, and clinical pharmacology expertise, coupled with our agile and flexible approach to clinical manufacturing and commercial manufacturing, make us the ideal partner.

From pre-formulation and formulation development through clinical development and scale-up for commercial manufacturing, we provide an end-to-end solution for the development of orphan drug products. Our extensive expertise and capabilities for orphan drug development include:

  • Pre-formulation and API characterisation.
  • Formulation and process development.
  • First-in-human clinical testing and acceleration into POC trials.
  • Bespoke clinical manufacturing and supply (Phase I-III) of drug products into patient trials.
  • Rapid scale-up and commercial manufacturing of low-volume products.
Contact our experts
As a fully integrated drug development, clinical testing and manufacturing organization, Quotient Sciences addresses the challenges associated with developing programs for rare diseases and orphan drug development . We are dedicated to accelerating the development of new drugs for patients around the world providing individual services or fully integrated programs through our unique Translational Pharmaceutics platform. Connect with us today to learn how we can help support the development and manufacturing needs of your orphan drug program.
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