Orphan drugs are a pharmaceutical agent that has been developed specifically to treat a rare medical condition. These are rare diseases classified strictly according to their prevalence, specifically “any disease or condition that affects 1 in 2500 in the EU”.
Quay Pharma are perfectly equipped to deliver an Orphan Drug molecule from pre-clinical and formulation development all the way to small scale commercialisation. As a small sized CDMO we are technically strong and creative in the development of solid oral, semi solids and liquid dosing.
Advantages of Using Quay Pharma For Your Orphan Drug Include:
- Working with small amounts of your API to handle your validation process.
- We can offer XcelolabTM to dose neat API into capsule
- Our set-up costs are low because the size of our business and our overheads
- Helping you with any registration and validation if and when required
We have experience in working with various Orphan Drugs companies and their API’s. We are a fee for service organisation and don’t hold any IP for any formulation of drug delivery platform that we use – these will remain with our clients.