GMP Manufacturing Services For Clinical Trials

Services offered by the facilities include:

  • The aseptic manufacturing of large and small volume liquids

  • The non-sterile manufacturing of a range of dosage forms

  • Ambient, refrigerated and frozen storage

  • Label design (adheres to Annex 13), printing and application

  • Primary and secondary packaging, including blinding of IMP

  • Fully trained staff

  • Distribution to clinical trial sites

  • GMP QC

  • Product certification and release by a QP

  • Current EU GMP standards

  • Home Office licence to order, store supply and possess as part of a clinical trial

  • MHRA MIA (IMP) licence

PRODUCTS

 

The types of products that we may work with include:

 

Capsules, liquids, tablets and other dosage forms for use in:

  • The gastro-intestinal system

  • The cardiovascular system

  • The respiratory system

...

STERILE WORK

 

Sterile production is undertaken in the accredited aseptic manufacturing suite operating at a range of environments up to grade ‘B’ EU GMP standards. The unit operates two Envair CDC-‘F’ grade ‘A’ negatively pressured isolators with

...

NON-STERILE WORK

The facility has the following equipment available for use in non-sterile production in an EU GMP standard grade ‘C’ environment:

  • Atlas Clean Air biosafety laminar flow cabinet

  • Balances of up to 5 decimal places

...

PHARMACEUTICAL EXCELLENCE

DELIVERING FOR YOU

ABOUT US

The GMP Manufacturing Facility For Clinical Trials

MAC focuses on manufacturing medications for Phase 1 through phase 3 studies. We support both independent research centres and the NHS in conducting clinical trials. MAC Clinical Research is the UK's largest neuroscience research company dedicated to the recruitment and management of clinical trials. MAC currently has eight dedicated research centres across the UK conducting trials from complex early phase all the way to Phase IV studies for a wide range of therapeutic areas.

CONTACT US

MAC's GMP-compliant facility is located in Leeds and we have additional aseptic facilities in Manchester.

MAC Clinical Research

Clinical Research Centre

Monarch House

Wakefield Road

Leeds

LS10 1DU

United Kingdom

MAC Clinical Research

Neuroscience Centre of Excellence

Citylabs 1.0

Nelson Street

Manchester

Greater Manchester

M13 9NQ

United Kingdom

If you would like to discuss your GMP requirements please complete the webform below. We will contact you shortly:

Data Privacy Statement

The data you share on this online form will be sent to the MAC Feasibility and Proposals  team who are responsible for responding to your request. The data will be stored according to the General Data Protection Regulation, which is designed to protect your privacy. If you do not wish to have the data you share on this form stored, you can request for it to be deleted at any time by contacting MAC Clinical Research.

 

Leading the way with GMP manufacturing for clinical trials in the UK

© 2019  MAC Research Ltd.  All rights reserved.

MAC GMP Manufacturing Facility | Wakefield Road, Leeds, LS10 1DU, United Kingdom | Tel: 0113 272 8910