OUR CONTRACT PHARMACEUTICAL SERVICES

Company Overview

SPECIAL DRUG MANUFACTURING

We hold an MRHA license for the manufacture and supply of ‘specials’.

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Specials supply can be manufactured on site at Quay Pharma, one of the limited number of contract manufacturers who hold an MRHA license for the manufacture and supply of ‘specials’.

Specials supply is unlicensed medicinal products required by patients who have clinical needs that cannot be met by licensed products.

Subject to strict prescribing rules, specials are vital in treating rare diseases and diseases that affect only a very small proportion of the population.

We manufacture specials to full GMP standards and subject to all of our regular process validation and stability testing procedures, including preservative efficacy data for liquids.

Our capabilities include:

  • Oral solid dose.
  • Liquid formulations.
  • Topical formulations.
  • Spray drying technologies.
  • ‘named-patient’ basis.
Your Dedicated Contacts
Dr Ivan Langan
Business Development Manager
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A PhD organic synthetic chemist with over 13 years’ experience in the clinical trials industry holding a number of roles within Operations and Business development. Prior to entering the clinical trial industry Ivan had worked in chemical manufacturing. With over 9 years’ experience gained in the manufacturing of API & chemical intermediates, gaining a breadth of knowledge & experience in both batch & continuous manufacture, from kilo to multi tonne scale along with holding a number of managerial positions during this time.

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Mike Frodsham
Chief Technical Officer
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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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