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Pharmaceutical auditors

About Clarion Quality

We provide GMP audits, GMP supplier audits, Pharmaceutical Quality System (PQS) and Quality Management System (QMS) support.

With 30 years of experience within public and private sectors: firsthand experience of implementing ISO/IEC 9001 quality management systems for general business governance; ISO/IEC 17025 for testing and calibration laboratories; as well as the good manufacturing practice (GMP) regulations for human and veterinary medicines.  

From R&D in drug discovery, through pilot scale to full-scale manufacture, Clarion Quality provides consultancy in good manufacturing practice (GMP), good laboratory practice (GLP), and GMP where it meets good clinical practice (GCP) for clinical trials.

For the GXPs, we can align your quality system to meet MHRA, EMA, FDA, TGA or any other target market's requirements as necessary.

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Approach & Values

At Clarion Quality, our work is underpinned by a commitment to quality culture and ethical leadership.

We believe effective pharmaceutical auditors must do more than secure regulatory approval; we help businesses establish sustainable practices, transparency, and integrity at every level. Our compliance-led consultancy means every service is carefully designed to fulfil the requirements of international standards, securing operational assurance and regulatory confidence. We aim to help your teams embed the right behaviours and attitudes for lasting improvement, fostering a culture where quality is valued and maintained.

Our practical, hands-on experience as pharmaceutical regulatory consultants, combined with our international perspective, allows us to deliver advice that is both business-focused and relevant to current industry challenges. We keep our clients fully informed on developments in ISO 9001 quality management, ISO 17025 laboratory compliance, and the evolving regulatory environment.

 

 
 
 

Consultancy

Our consultancy service encompasses the full range of pharmaceutical quality requirements:

 
  • Support with Pharmaceutical Quality Systems (PQS) and GMP for medicines manufacture
  • Guidance on importation, product quality control testing, and acceptance
  • Expert advice on GMP Part I (general requirements), Part II (active substances and APIs), and Part III (documentation and compliance)
  • Inspection readiness, including audit preparation, personnel training, and mentoring
  • Annex 1 manufacturing (aseptic processing, sterile liquids, closed systems)
  • Annex 13 on Investigational Medicinal Products and requirements for Specials Licence therapies

  • Advanced Therapy Medicinal Products compliance
  • Remediation activities following audit or regulatory findings
  • Good Laboratory Practice (GLP) and pharmaceutical quality control
  • GMP aligned clinical trial support, where GMP meets GCP
  • ISO 9001:2026 quality management systems for industry, manufacturing, and service providers
  • ISO 17025:2017 compliance consultancy for laboratories

Our approach ensures organisations are ready for regulatory scrutiny and ongoing operational excellence.

 
 
 

Audits

 

Clarion Quality provides sector-leading audit services through highly trained, industry-qualified auditors:

  • LRQA & JEMO Qualified ISO 9001 Lead Assessor
  • PS 9000 Lead Assessor
  • UKAS ISO 17025 Lead Assessor

Our audit services include:

  • Gap analysis and benchmarking against international best practice
  • QMS revision for continual improvement
  • Organisation-wide training to embed compliance
  • GMP site inspections and supplier audits
  • Pre-contract placement inspections and surveillance audits for GMP
  • Clinical trial importation hub audits

With over 25 years' global supplier auditing experience and more than a decade as cGMP Quality Manager, our team gives you the assurance of MHRA compliance consultancy at the highest standard.

Audits Service

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Training

We provide a suite of training options, from introductory to bespoke in-house modules, to support ongoing regulatory compliance and skills development:

 

 
  • Good Manufacturing Practice (GMP) for pharmaceutical manufacture and Investigational Medicinal Products (IMPs)
  • GMP for pharmaceutical laboratories, including active substance manufacture (GMP Part II)

  • ISO/IEC 17025:2017 requirements for the competence of testing and calibration labs (supporting both in-house QC and subcontracted labs)
  • ISO/IEC 9001:2026 quality management systems for manufacturing and service sectors

The transition to ISO 9001:2026 introduces enhanced focus on quality culture, ethical leadership, and digital integration, and Clarion Quality is ready to support organisations updating their systems during the three-year transition period.

 

 
 

Frequently Asked Questions

What qualifications do Clarion Quality auditors hold?

Clarion Quality auditors are LRQA & JEMO Qualified ISO 9001 Lead Assessors, PS 9000 Lead Assessors, and UKAS ISO 17025 Lead Assessors, offering top-tier pharmaceutical audit and compliance expertise.

What industries has Clarion Quality worked with?

We work with the pharmaceutical industry, laboratories, manufacturers, and service sectors, supporting GMP, ISO 9001, and ISO 17025 compliance.

What services does Clarion Quality offer as pharmaceutical auditors?

Our services include GMP audits, supplier audits, Pharmaceutical Quality System support, ISO 9001 and ISO 17025 consultancy, and regulatory training.

How does Clarion Quality support MHRA and ISO compliance?

We align quality management systems to meet MHRA, EMA, FDA, TGA, ISO 9001:2026, and ISO 17025:2017 requirements for UK and global regulatory compliance.

What training packages are available from Clarion Quality?

We offer introductory, bespoke, and in-house training in GMP, ISO 9001, ISO 17025, and pharmaceutical quality systems for teams and organisations.

How can I contact Clarion Quality for pharmaceutical audit or consultancy?

You can reach us by email at contact@clarionquality.co.uk or call +44 (7941 640 894) to discuss your pharmaceutical audit or quality consultancy needs.

 

 
 

Take the Next Step Towards Compliance Excellence

Discover how Clarion Quality can help your organisation achieve robust pharmaceutical quality systems and simplify regulatory compliance. Reach out today and let our expert team guide you, contact us now for a prompt response and personalised support.

 

 

Clarion Quality GXP UK Limited - Company number 12675976 - Registered in England & Wales