OUR CONTRACT PHARMACEUTICAL SERVICES

Company Overview

PHASE 1 CLINICAL MANUFACTURING

We are extensively involved in developing early clinical formulations and clinical manufacturing of First in Human trials.

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We can develop a formulation specifically designed to achieve your targets during the crucial first clinical evaluations of your API.

We will provide the formulation’s clinical supplies in the most appropriate form. This is likely to be either a simple powder-in-capsule dose or powder in a bottle ready for reconstitution prior to dosing.

The well-proven early-stage manufacturing technologies we offer include:

  • Xcelolab system to fill neat API into bottles or capsules ready for Phase I trials.
  • Providing the formulated drug in a bottle, in a form designed to offer improved reconstitution and solubility.

For these or any other system you require, we will provide all of the analytical, preformulation, and formulation data necessary for your clinical trial.

We aim to rapidly and cost-effectively supply you with a product that maximises the chances of the early clinical evaluation being successful and provide you with all the information and data required for your IMPD submission.

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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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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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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