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GOOD LABORATORY PRACTICE


Kymanox uses the principle of Ideal Knowledge Transfer™ (IKT) to help your organization address the challenges of complying with Good Laboratory Practice (GLP) regulations while increasing confidence in your scientific research. The Kymanox team has a diverse background and proven past performance in lab bench research, analytical science, in vitro diagnostics, quality control, and translational medicine.


GLP Compliance


With expert knowledge across multiple disciplines, Kymanox helps eliminate the ambiguity surrounding regulations and published guidance (e.g., FDA, EMA, EPA, OECD, CLIA, CAP, MHRA) to provide clear and concise end-requirements along with best-in-class services to our clients in the pre-clinical and laboratory research space. Kymanox operates confidently in both proactive and reactive situations to ensure your needs are efficiently and effectively satisfied.

The Kymanox GLP Compliance team provides services in the following areas:


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    • Gap Assessments

    • Development of SOPs and Validated Methods

    • Training and Implementation of Protocols

    • Third Party Audits and Vendor Management

    • Development and Delivery of Customized GLP Training

    • Internal Sponsor Audits, Investigator Site Audits, and Quality Agreements

    • Regulatory Inspection Preparation (i.e., Mock Audits)

    • Microbiology and Toxicology Subject Matter Experts

    • Animal Studies Support

    • Good Documentation Practices and Data Integrity Implementation and Monitoring

    Synergy with All Kymanox Services


    Kymanox holds a 360° view of GLP and leverages our service offerings with additional capabilities:

      • Analytical Sciences, Validation, and Process Engineering

      • Project Management and Training

      • Quality Assurance and Regulatory Compliance

      Integrating science, business, and compliance with a focus on your laboratory documentation, Kymanox helps you avoid costly and often irreversible missteps. Together with you, we help implement GLP quality systems that produce documentation to support Right First Time (RFT) decisions and regulatory submissions with scientific confidence.

        Your Life Science Solutions Partner For Good Laboratory Practice

        Biotechnology | Pharmaceuticals | Medical Devices | Combination Products