How can I enhance my orphan drug development?
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.
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Integrated capabilities and expertise
At Quotient Sciences we have supported over 50 development programs for rare disease in the past 5 years. Our extensive formulation know-how, clinical pharmacology expertise, coupled with our agile and flexible approach to clinical and commercial manufacturing, makes 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 includes:
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.
Advancing the Pharmaceutical Development of Orphan Drugs for Rare Diseases
With over 300 million people worldwide living with one or more identified rare diseases, the development of new treatments to address these unmet clinical needs is an area of significant focus in the pharmaceutical industry.
Accelerating the Developing of Orphan Drugs for Rare Diseases
Worldwide there are over 300 million people living with identified rare diseases. This white paper will discuss four principal CMC challenges for the developers of orphan drugs, and the potential solutions which are emerging.