Regulatory Compliance Solutions

  1. 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.

  2. A Leading Digital Validation Platform For Life Sciences 12/17/2024

    Discover Kneat Gx, a leading digital validation platform trusted by top Life Sciences companies, reducing validation time and costs while enhancing compliance, scalability, and efficiency.

  3. Sterility Testing For Cell Therapy Bioproduction Samples 6/20/2024

    This useful tool helps to ensure quality and safety in cell therapy products through the use of a probe-based quantitative PCR (qPCR) assay to detect bacterial and fungal species.

  4. 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.

  5. IDBS PIMS And Regulatory Compliance 4/4/2025

    Approach for US FDA 21 CFR Part 11 electronic records and electronic signatures: IDBS PIMS has been designed, developed and tested to enable compliance to 21 CFR Part 11 to accommodate the regulatory needs of its users.

  6. V31 Print Inspection System: Print Quality And Barcodes 11/14/2024

    The V31 Print Inspection System ensures label quality, verifying barcodes and text, and automatically rejects faulty labels, enhancing compliance and efficiency in labeling processes.

  7. Reliable. Confident. Environmental Monitoring. 5/19/2025

    Optimize cleanroom operations with innovative monitoring systems that provide real-time data, improve investigations, and support regulatory compliance for aseptic environments.

  8. Process Development 4/27/2022

    At Kymanox, our biopharmaceutical, medical device, and packaging experts establish and improve manufacturing processes guided by Quality by Design (QbD) principles. Our risk-based approach ensures your processes are efficient, consistent, cost-effective, and meet regulatory requirements for safety and quality.

  9. Chemistry, Manufacturing, & Controls 4/27/2022

    At Kymanox, our science-centric Chemistry, Manufacturing, & Controls (CMC) team has global experience in strategic planning and authoring regulatory submissions (e.g., US FDA, EU EMA) for the pharmaceutical, biologic, and combination product (e.g., drug and device) industries. Our multi-disciplinary approach combines expert product and process knowledge with a quality-first mindset to ensure Right First Time submissions.

  10. Global Technical Services 10/15/2024

    From risk assessment to bio-decontamination solutions, drive continuous improvement in contamination control with tailored expert support.