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Company Overview

ORPHAN DRUG DEVELOPMENT

The pharmaceutical agent that has been developed specifically to treat a rare medical condition.

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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
Michael Kruidenier
Head of Business Development
(Live-Biotherapeutics)
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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.

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Mike Frodsham
Chief Technical Officer
(CTO)
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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.

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Our Pharmaceutical Services

Preclinical Formulation

Robust formulation development strategies tailored to the characteristics of each individual API.

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Pharmaceutical Preformulation

Analysis of Active Pharmaceutical Ingredients (APIs), including those that present particular challenges.

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Pharmaceutical Formulation Development

Dosage form optimisation for a wide range of product types including those that have poor solubility or bioavailability.

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Analytical Services

Analytical specialists working alongside our formulation and manufacturing teams which provide expert advice.

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Phase I Clinical Manufacturing

Early clinical formulations and clinical manufacturing of First in Human trials and clinical evaluations of your API.

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Phase II & III Clinical Manufacturing

Fully equipped and accredited to manufacture a wide range of products for Phase II and small-scale Phase III trials.

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Commercial Manufacture & Packaging

MHRA licensed to include commercial manufacture. Services include contract packaging and assembly...

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Controlled Substances

Over ten years of extensive development and manufacture experience converting controlled substances into a variety of different dosage forms.

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Clinical Trial Supply

Complete range of clinical trial supply packaging for solid and liquid dosages. Despatched with full QP release certification.

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Live Biotherapeutics Drug Delivery

One of the few companies licensed for the clinical manufacture of live biotherapeutics products.

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Orphan Drugs

Perfectly equipped to deliver an Orphan Drug molecule from preclinical and formulation development to small scale commercialisation.

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Specials Manufacturing

One of the limited number of contract manufacturers who hold an MRHA license for the manufacture and supply of ‘specials’.

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Let's Talk Project Success

Talk directly to the Quay staff - Our dedicated team leaders are ready to listen and help with your project.

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