OUR CONTRACT PHARMACEUTICAL SERVICES

Company Overview

EXPERT ANALYTICAL FORMULATION SERVICES

Our analytical insight provides expert advice and an enormous breadth of knowledge to your project.

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Quay Pharma has hugely experienced analytical specialists working alongside our formulation and manufacturing teams who provide expert advice and an enormous breadth of advanced analytical capabilities.

Quay Pharma has hugely experienced analytical specialists working alongside our formulation and manufacturing teams who provide expert advice and an enormous breadth of advanced analytical capabilities. Their contribution is vital in our success in early-stage formulation development, stability studies, and clinical trial manufacture.

Analytical Services Include:

  • Analytical method transfer, development and validation.
  • Stability-indicating assays using UPLC and HPLC (including forced degradation studies).
  • Formal and informal stability study design, storage and testing.
  • Batch release and raw material testing.
  • Chemical and physical testing.
  • Chiral analysis.
  • Dissolution testing and drug release profiling.
  • Drug substance characterisation.
  • The identification and quantification of impurities.
  • Comparator studies.
  • Testing of raw materials to ensure that each formulation component meets our quality requirements.
  • In-process assays to establish that the manufacturing processes are meeting the standards set out in advance.
  • Carrying out of final product assays to verify that product meets its specification.
  • We employ stability testing to evaluate the useful shelf life of the product.
Your Dedicated Contacts
Maura McArdle
Head of Business Development
(Formulation Development)
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Maura McArdle joined Quay as Head of Business Development for Europe in 2019. Maura’s appointment is to ensure continued focus on Quay’s core business, Pharmaceutical Development of small molecule compounds. With a degree in Chemical Engineering, Maura has over 20 years of business development experience into the Chemical and Pharmaceutical industries having previously worked for Almac, Brenntag and BASF.

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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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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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