Your Trusted Quality Compliance Partner
Independent consultancy offering quality assurance, auditing, regulatory compliance, and product safety expertise across clinical research, pharmaceutical, and healthcare sectors.
Committed to Quality and Compliance
We specialize in delivering professional quality consulting services.
Our team is dedicated to ensuring the highest standards of compliance.
Trust our expertise to navigate complex regulatory landscapes.
Partner with us for a safer and compliant future.
2025
Established in
EU/UK
Operating in
7+
Years of Regulatory/QA experience
Regulatory Compliance
Deep Understanding of Global Frameworks: We possess an intricate knowledge of international and local regulatory requirements across various industries, including GDPR, ISO 9001, ISO 13485, MHRA/FDA/EMA guidelines and much more.
Strategic Compliance Road-mapping: We don't just identify gaps; we design and implement comprehensive, forward-thinking compliance strategies tailored to your unique business needs and objectives.
Risk Mitigation and Gap Analysis: Our approach involves rigorous assessment to pinpoint compliance risks and develop robust mitigation plans, ensuring adherence and minimizing potential liabilities.
Continuous Regulatory Intelligence: Staying abreast of evolving legal and regulatory changes, we provide ongoing insights and adjustments to keep your business ahead of emerging requirements.
GMP & Quality Assurance Excellence
GMP System Design & Implementation: Leveraging profound knowledge of EU GMP, FDA cGMP and ISO standards, we design and optimise Quality Management Systems that are robust, compliant and operationally efficient across pharmaceutical, cosmetic and manufacturing sectors.
Batch Release & Product Lifecycle Integrity: Our expertise covers the critical principles of batch certification and release, ensuring product quality and compliance throughout the entire lifecycle, from raw material to finished product.
Regulatory Inspection Readiness: With a deep understanding of regulatory expectations, we prepare your facility for successful inspections by MHRA, FDA, EMA and other competent authorities, identifying and mitigating potential non-compliance.
Deviation, CAPA & Change Control Management: We implement and refine systems for effective handling of deviations, CAPAs, and change controls, driving continuous improvement and ensuring product quality.
Supply Chain Quality Assurance: Extending quality oversight across your entire supply chain, from supplier qualification to distribution, ensuring product integrity and regulatory adherence at every stage.
Clinical Research Support
Our dedicated support goes beyond mere assistance; we provide comprehensive quality assurance and strategic guidance at every stage of your clinical research journey. Leveraging deep expertise in global regulatory frameworks, we empower your team to navigate complexities with confidence and achieve scientifically sound, compliant and ethical outcomes.
Regulatory Mastery: In-depth knowledge of ICH GCP, FDA, EMA and country-specific guidelines ensures your trials meet the highest international standards.
Proactive Quality Management: We implement risk-based strategies to identify and mitigate potential issues before they impact your study integrity.
Operational Excellent: Optimising processes and providing tailored solutions to enhance efficiency and accelerate your path to successful clinical trial completion.
Get in touch
E-mail: aaron@qualityconsulting.uk
Address: Lancashire, Preston