BIOANALYTICAL SERVICES FOCUS AREA
An orphan drug is a pharmaceutical agent used to treat medical conditions, which, since they are so rare, would not be profitable to produce without government assistance. The formal definition, in the US, is diseases affecting fewer than 200,000 people, and in the EU, diseases affecting fewer than 10,000 people.
Given the overall rarity of the disease/condition, the incentive for developing and financing an orphan drug has historically been low. However, recent legislation incentives have created a global effort in the clinical development of orphan drugs, and at Svar, we can assist with risk assessment and assay strategies within relevant service fields.
Contact us to discuss your project with our scientists today!
We have experience in orphan drug bioanalytical development/validation and sample analysis, as well as general Bioanalytical program designing. Due to our collaborative approach, we are adaptive to bioanalytical strategies for small sample sizes, etc.
In parallel to this, we can aid with understanding the regulatory landscape and assist when setting up risk analysis to meet compliances.