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 is perfectly equipped to deliver an orphan drug molecule from pre-clinical and formulation development 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.
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.
Your Dedicated Contacts
Head of Business Development (Live-Biotherapeutics)
Michael joined Quay Pharma in Sept 2013 and he is responsible for all global Live Biotherapeutic business and for all other business outside Europe. Most of Michael’s career has been spent in commercial roles. He has over 30 years of Sales and Marketing experience, including 20 years in the pharmaceutical industry with Proctor & Gamble and SCA followed by working for leading contract service organisations PERA and Penn Pharma.
Mike has over 20 years’ experience in drug product development. For over 15 years he has been responsible for development activities at Quay Pharma. During this period Mike has overseen over 200 non-sterile development projects; predominantly taking NCE’s through to first in human studies and beyond. His background is in formulation science with a PhD in liquisolid dosage forms and is cited as an inventor on multiple oral formulation patents.