Consultancy in quality assurance of medicines manufacture
As dedicated pharmaceutical quality consultants, Clarion Quality delivers in-depth consultancy for every stage of medicines manufacture. Our work is grounded in ethical leadership and a strong quality culture, offering assurance that your compliance needs are in expert hands.
- Pharmaceutical Quality System (PQS) requirements:
We set up and optimise PQS according to current good manufacturing practice (GMP), ensuring your systems comprehensively manage documentation, deviation, and change control for consistent product quality. - Importation requirements:
Our consultants clarify and implement requirements for the importation of medicinal products, enabling legal, compliant transfer across borders and supporting your market expansion. - Product quality requirements for QC testing and acceptance:
We design and review thorough quality control (QC) testing protocols, validating methods and acceptance criteria to meet international standards. - GMP Part I, General requirements:
We interpret and apply every aspect of GMP Part I for pharmaceutical manufacture, covering personnel, premises, hygiene, documentation, and more. - GMP Part II, Active substances / APIs manufacturing:
We specialise in GMP for active pharmaceutical ingredients (APIs), providing consultancy on manufacturing, control, packaging, and shipping requirements for both small and large molecules. - GMP Part III compliance:
Our team guides you through documentation of GMP-related guidelines, ensuring your facility aligns with additional requirements under GMP Part III. - Inspection readiness, audits, training and mentoring:
Clarion Quality prepares your sites for regulatory inspection with tailored internal audits, bespoke training, and mentoring for key personnel.
- GMP Annex 1, Manufacture of Sterile Medicinal Products:
- Aseptic processing: Advisory on facility design and process validation for contaminant-free production.
- Closed systems: Guidance on system integrity to prevent cross-contamination.
- Sterile liquids for injection/infusion: Expertise in terminal sterilisation, risk assessment, and environmental monitoring.
- Terminally sterilised product: Process review for robust, regulatory-compliant manufacturing.
- GMP Annex 13, Investigational Medicinal Products:
Support with compliance for clinical trial manufacturing, labelling, and release. - Therapies manufactured under Specials Licence:
Practical consultancy on unlicensed medicines under UK legislation, improving patient care while meeting quality expectations. - Advanced Therapy Medicinal Products (ATMPs):
Guidance on manufacturing requirements and documentation for cell, gene, and tissue-engineered therapies. - Remediation activities:
Troubleshooting and resolving compliance gaps with risk-based remediation and root cause analysis. - GLP and pharmaceutical quality control:
Complete support with Good Laboratory Practice (GLP) covering both quality and technical management in laboratories. - Where GMP meets GCP:
Ensuring continuity and compliance at the interface of manufacturing and clinical trials for investigational medicinal products.
As pharmaceutical quality system consultants, Clarion Quality offers clarity, reliability, and depth of experience in all these regulatory areas, underpinning pharmaceutical industry quality wherever you operate.
For business, manufacturing and service industries
At Clarion Quality, our consultancy extends to manufacturing and service industries seeking robust quality systems beyond the pharmaceutical sector.
ISO 9001:2026 Quality Management Systems
We implement and maintain ISO 9001:2026-compliant quality management systems for businesses, streamlining performance and supporting a sustainable culture of quality.
Process improvement
We analyse and optimise your business workflows, reducing inefficiencies and enhancing compliance.
Supplier and contractor qualification
Our team evaluates suppliers and contractors for consistent standards and alignment with your organisation's quality objectives.
For laboratories, Clarion Quality specialises in establishing and auditing:
- ISO 17025:2017 for Test and Calibration Laboratories: We guide laboratories through accreditation, creating strong management and technical procedures that deliver reliable, compliant results.
Frequently Asked Questions
What does pharmaceutical compliance consultancy involve?
Pharmaceutical compliance consultancy covers regulatory advice, GMP, GLP, PQS, and ISO support to ensure your organisation meets industry standards.
How can consultancy help improve our quality management system?
Consultants assess current practices, implement ISO 9001 or PQS, refine procedures, and foster a compliance-led quality culture that improves operations.
Can you help organisations implement GMP or GLP systems?
Yes. Clarion Quality supports the full implementation of GMP or GLP systems, including staff training, process design, and ongoing compliance checks.
Do you provide support for regulatory inspection readiness?
We prepare organisations for inspections with audits, bespoke training, mentoring, and on-site or remote readiness assessments to ensure full compliance.
Can Clarion Quality assist with remediation following an audit or inspection?
Absolutely. We diagnose compliance gaps, offer remediation advice, and personalise corrective actions to restore and maintain regulatory standards.
How long does it take to implement a compliant quality system?
Timeframes vary by organisation size and complexity, but Clarion Quality provides a tailored roadmap for implementing pharmaceutical quality management systems.
Arrange your pharmaceutical consultancy services
To discuss how Clarion Quality can support your pharmaceutical site audits, GMP inspections, or supplier qualifications in the UK, please contact us as our helpful team is ready to assist.
Services
Clarion Quality GXP UK Limited - Company number 12675976 - Registered in England & Wales