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 EU its 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 has created a global effort in the clinical development of orphan drugs and at Wieslab, we can assist with risk assessment and assay strategies within relevant service fields.
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 parallell to this we can aid with understanding the regulatory landscape and assist when setting up risk analysis to meet compliances.