Our Services

  • CAP (College of American Pathologists) All Checklists
    ISO/IEC 17025:2017
    ISO 9001
    FDA
    AABB
    Code of Federal Regulations (CFR)
    State Administrative and Revised Code
    GCP
    GLP
    CLIA ‘88

    • Creation and Implementation of Quality Management Systems (QMS): Develop comprehensive QMS frameworks tailored to organizational needs, ensuring alignment with regulatory standards and fostering continuous quality improvement.

    • Policy and Standard Operating Procedure Development and Review: Draft, evaluate, and update policies and SOPs to maintain regulatory compliance and operational excellence.

    • Competency Assessment Plans, Documents, Checklists, and Exams and Implementation: Design and deploy structured competency assessment tools to verify staff qualifications, ensuring consistent performance and adherence to best practices.

    • Quality Control Plan Design and Implementation: Establish rigorous quality control protocols that monitor processes and outputs, enabling early detection and correction of deviations.

    • Semi-Annual Correlation Studies: Conduct periodic correlation analyses to validate accuracy and reliability of testing procedures, supporting accreditation requirements and quality assurance objectives.

  • Comprehensive Training Plans and Materials
    Our consulting services develop meticulously tailored training plans and materials that adhere strictly to current regulatory standards, ensuring your team is equipped with up-to-date knowledge and skills to maintain compliance effectively.

    Staff Training Sessions and Competency Verification
    We facilitate targeted training sessions designed to reinforce regulatory requirements and best practices, coupled with robust competency verification processes to confirm staff proficiency and readiness in compliance protocols.

    Customized Checklists for Ongoing Compliance
    We create bespoke checklists that align with regulatory frameworks, enabling your organization to systematically monitor and sustain compliance through regular, structured reviews and proactive adjustments.

  • Method Development, Review, and Validation/Verification of Assays and Equipment

    • Rigorous optimization of analytical methods to ensure accuracy and reproducibility

    • Comprehensive review cycles to maintain compliance and performance standards

    • Validation and verification protocols tailored to specific assays and instrumentation

    Implementation of New Testing Services

    • Strategic integration of cutting-edge assays into existing workflows

    • Seamless adoption driven by thorough feasibility assessments and pilot studies

    • Continuous monitoring and refinement to maximize reliability and throughput

    Laboratory Software Configuration, Procedure Development, and Staff Training

    • Custom configuration of laboratory information management systems (LIMS) for enhanced data integrity

    • Development of clear, compliant standard operating procedures (SOPs) to standard

    Method Development, Review, and Validation/Verification of Assays and Equipment

    • Rigorous optimization of analytical methods to ensure accuracy and reproducibility

    • Comprehensive review cycles to maintain compliance and performance standards

    • Validation and verification protocols tailored to specific assays and instrumentation

    Implementation of New Testing Services

    • Strategic integration of cutting-edge assays into existing workflows

    • Seamless adoption driven by thorough feasibility assessments and pilot studies

    • Continuous monitoring and refinement to maximize reliability and throughput

    Laboratory Software Configuration, Procedure Development, and Staff Training

    • Custom configuration of laboratory information management systems (LIMS) for enhanced data integrity

    • Development of clear, compliant standard operating procedures (SOPs) to standardize practices

    • Dedicated training programs designed to empower staff with skills and knowledge for optimal laboratory performance

  • Workflow Analysis and Process Streamlining

    • Evaluate current laboratory operations to identify bottlenecks and inefficiencies

    • Map processes visually to uncover redundancies and delays

    • Apply lean methodologies to optimize task sequences and reduce waste

    Laboratory Layout and Design Improvement

    • Assess spatial arrangement for improved safety and functionality

    • Incorporate ergonomic principles to enhance staff comfort and productivity

    • Design modular workstations to accommodate evolving research needs

    Implementation of Laboratory Operations for Optimal Efficiency

    • Standardize protocols to ensure consistency and quality

    • Leverage automation tools to minimize human error and speed workflows

    • Train personnel thoroughly to maintain operational excellence and adaptability