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ANALYTICAL SCIENCES


The Kymanox Analytical Sciences group has professionals with global experience in the pharmaceutical, biotechnology, medical device, and in vitro diagnostic industries. We provide ongoing support for all phases of development, from discovery to post-commercialization. With a comprehensive library of proven templates covering study design through final reporting, we meet required timelines and maximize effectiveness and efficiency.

Analytical Sciences

Phase-Appropriate Analytical Support


Kymanox provides support in the following areas:

    ANALYTICAL SCIENCES


    The Kymanox Analytical Sciences group has professionals with global experience in the pharmaceutical, biotechnology, medical device, and in vitro diagnostic industries. We provide ongoing support for all phases of development, from discovery to post-commercialization. With a comprehensive library of proven templates covering study design through final reporting, we meet required timelines and maximize effectiveness and efficiency.

    Analytical Sciences

    Phase-Appropriate Analytical Support


    Kymanox provides support in the following areas:

      • Analytical Method Characterization, Development, and Validation

      • Laboratory Equipment and Instrument Qualification

      • Cleaning Method Development and Disinfectant Efficacy

      • Formulation and Process Development and Optimization

      • Microbiological Identification and Method Validation

      • Stability Program Development and Oversight

      • Advanced Statistical Data Analysis

      • Turnkey Documentation Development

      • Remediation Support for CGMP Inspection Observations

      • PAI Support of Analytical Laboratories and GLP Inspections

      • Design and Setup of CGMP and GLP Analytical Laboratories

      • Quality Operations Support


      Synergy with Kymanox Services


      Kymanox holds a 360° view of all operations and augments our analytical sciences services with additional capabilities:


      • Validation and Process Engineering

      • Project Management and Training

      • Quality Assurance, Quality Control, and Regulatory Compliance

      Integrating our science, engineering, quality, and compliance capabilities, Kymanox helps you avoid costly and often irreversible missteps. Together with you, Kymanox helps select optimal procedures, methods, and equipment to develop effective and controlled analytical science programs from early product development through commercial manufacturing.


      YOUR LIFE SCIENCE SOLUTIONS PARTNER FOR CGxP ANALYTICAL SCIENCES

      • Analytical Method Characterization, Development, and Validation

      • Laboratory Equipment and Instrument Qualification

      • Cleaning Method Development and Disinfectant Efficacy

      • Formulation and Process Development and Optimization

      • Microbiological Identification and Method Validation

      • Stability Program Development and Oversight

      • Advanced Statistical Data Analysis

      • Turnkey Documentation Development

      • Remediation Support for CGMP Inspection Observations

      • PAI Support of Analytical Laboratories and GLP Inspections

      • Design and Setup of CGMP and GLP Analytical Laboratories

      • Quality Operations Support



      Synergy with Kymanox Services


      Kymanox holds a 360° view of all operations and augments our analytical sciences services with additional capabilities:


      • Validation and Process Engineering

      • Project Management and Training

      • Quality Assurance, Quality Control, and Regulatory Compliance

      Integrating our science, engineering, quality, and compliance capabilities, Kymanox helps you avoid costly and often irreversible missteps. Together with you, Kymanox helps select optimal procedures, methods, and equipment to develop effective and controlled analytical science programs from early product development through commercial manufacturing.


      YOUR LIFE SCIENCE SOLUTIONS PARTNER FOR CGxP ANALYTICAL SCIENCES


      Biotechnology | Pharmaceuticals | Medical Devices | Combination Products