Regulatory Compliance Solutions

  1. Analytical Sciences 4/27/2022

    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.

  2. Drug Product Fill Finish And Formulation Solutions

    Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.

  3. Pharmaceutical Electronic Batch Records (EBR) Software 2/28/2023

    CGMP software helps automate and standardize processes to get to market faster. GMP quality systems connect and ensure quality throughout the product life cycle. Information is maintained in a central location. Compliance is simple.

  4. Commissioning, Qualification, Regulatory Compliance Services 4/27/2022

    We help you implement innovative approaches that help you achieve higher quality, increased reliability, faster project delivery, reduced energy and operating costs, and an integrated, business focused approach to regulatory compliance.

  5. SCIEX M5 MicroLC System 9/6/2023

    See More with Microflow LC-MS

    The M5 MicroLC system is the perfect balance of sensitivity and robustness—more sensitive than traditional analytical flow LC, and more flexible and more robust than nanoflow LC — giving you the potential to optimize your critical workflows, today and into the future.

  6. Human Factors Regulatory & Strategy 4/27/2022

    At Kymanox, the Human Factors Regulatory and Strategy (HURAS) team provides comprehensive support for human factors regulatory strategy and usability engineering from product conception through post-market and lifecycle management stages. Our team leverages the extensive expertise within Kymanox to deliver an integrated approach for your product development strategies and programs including Quality, Regulatory, Engineering, and Validation.

  7. Columns To Optimize Your GC Analysis 6/14/2023

    Optimize Your GC Analysis with Zebron GC Columns

    Zebron GC columns are engineered with quality of analysis in mind to better support scientists' research and regulatory analysis for environmental, food safety, food quality, forensics, pharma, fuels, and specialty chemicals.

  8. Technology Transfer 4/28/2022

    At Kymanox, our branded Technology Transfer methodology combines technical project management, sound science and engineering, quality and regulatory expertise, and business acumen to ensure Right First Time execution. Our approach is heavily based on following CGxP documentation best practices and has been honed over a decade of proven past performance.

  9. Quality Engineering 4/27/2022

    At Kymanox, we provide end-to-end engineering and compliance solutions for all stages of your product’s life cycle. Our Quality Engineering team utilizes a risk-based, patient-centric approach and partners with you to commercialize modern drug/biologic products, medical devices, and combination products.

  10. Pick Up To 3000 Colonies Per Hour Using The QPix Microbial Colony Pickers 6/21/2023

    Automated microbial screening system capable of picking up to 3,000 colonies per hour

    The QPix® Microbial Colony Picker leverages best-in-class colony picking technology to alleviate bottlenecks and quickly, accurately, and efficiently screen through massive genetic libraries. The easy-to-use, intuitive software guides users through setting up colony picking runs where precision robotics pick the right colonies every time.. In addition to microbial screening, the system automates several sample preparation and plate handling processes such as transfer of bacterial liquid culture and plating on agar.