Regulatory & Quality Assurance Services

Your Trusted Quality Partner

As a team of experienced international consultants, we specialise in supporting Academic Institutions, NHS, Not-For-Profit’s, BioTech Start-Up’s, Pharmaceutical, Contract Research Laboratories & Organisations.

GLP

Ensure your studies meet regulatory requirements with GLP-compliant processes, for global regulations, compliance, and enhanced study credibility.

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GCP

Supporting clinical laboratories in meeting GCP requirements, ensuring patient safety, data integrity, and regulatory compliance in clinical trials.

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GCLP

Implementing GCLP frameworks, conducting audits, and optimising processes for accurate, reliable, and reproducible laboratory data in clinical research.

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Computerised System Validation (CSV)

Validate computerised systems to meet regulatory expectations, ensuring data integrity, security, and compliance with GLP, GCP, GCLP, and FDA 21 CFR Part 11.

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ISO Standards

Achieve ISO certification with expert guidance on ISO 9001, ISO 13485, ISO 17025, and ISO 15189, with robust quality management systems for operational efficiency and regulatory confidence.

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For Sponsors

Vendor audits, assessments, and compliance checks for GLP, GCP, GCLP, CSV, and ISO standards to meet regulatory expectations for successful clinical and non-clinical research.

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Who We Work With

As a team of experienced international consultants, we specialise in supporting academic institutions, NHS, Not-For-Profit’s, BioTech Start-Up’s, Pharmaceutical, Contract Research Laboratories & Organisations.

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    • Consultancy

    Tailored guidance to help you navigate the complexities of QA and regulatory compliance. Working closely with your team, we assess current processes, identify areas for improvement, and implement effective solutions.

    CONSULTING SERVICES

    Training

    Stay ahead in the ever-evolving regulatory landscape with our comprehensive training programs. Our customised training solutions are designed to equip your team with the latest knowledge and skills across QA and regulatory compliance.

    TRAINING SERVICES

    MEET THE TEAM

    The Knowlogy will never offer a one-size fits all solution.

    As an agile company, we provide bespoke services, from single solutions to comprehensive suites, to support your unique situations.

    IMG 4456 Enhanced NR scaled

    Cate Ovington

    Founder & Managing Director
    IMG 4460 Enhanced NR scaled

    Stuart Ovington

    Company Director
    IMG 4506 Enhanced NR scaled

    Elaine McLachlan

    Quality Consultant

    FAQs

    At The Knowlogy, we work with businesses across the BioTech and Pharmaceutical sectors. We’re proud to have worked with academic institutions, NHS, Not-For-Profit’s, and CROs.

    Our working engagement with each client is bespoke. This means that we work hard to understand your challenges and your goals, before suggesting and implementing the recommended course of action.

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    Get in touch

    Want to learn more about what we do, or how we can help you navigate regulatory and quality challenges?

    Speak to us