Regulatory Compliance Solutions

  1. 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.

  2. Class 2 Biological Safety Cabinet: Type B2 8/29/2023

    The Class 2, Type B2 Laminar Flow Biosafety Cabinet provides a high degree of localized protection from particulate and aerosol hazards. The work area is continuously bathed with laminar flow ISO 5/Class 100 HEPA-filtered air while creating a negative pressure airflow into the cabinet to provide user protection.

  3. eCTD Submissions And Registrations Software 8/31/2021

    MasterControl’s eCTD submission and product registration management software automates, simplifies and accelerates submissions and product registrations.

  4. Audit Management Software For Life Sciences 8/23/2021

    MasterControl’s audit management software system automates tasks so that companies can successfully pass audits.

  5. Instrument For Accurate Filter Integrity Testing 3/10/2022

    The Palltronic Flowstar V integrity test instrument ensures accurate filter integrity testing with a further reduction in test time, full compliance with 21 CFR Part 11, advanced automation capabilities, and simplified network integration saving the user time while improving process efficiency.

  6. Cleaning Validation 4/27/2022

    Kymanox understands that cleaning validation, as with all CGMP activities, should be a controlled, quality-driven process that manages risk and ultimately ensures a safe and effective product for the patient. Our science-driven and planning-focused approach delivers Right First Time (RFT) results.

  7. Packaging Technology & Engineering 4/27/2022

    The Kymanox Packaging Technology & Engineering group has global experience exclusively serving the Life Science industry. We provide comprehensive support for strategic planning, packaging system design, qualification, cold chain distribution, artwork, labeling, human factors engineering, manufacturing, serialization, and identification.

  8. Minimizing Uncertainty Throughout The Development Lifecycle

    Wearable technologies that allow for dosing of high-volume biologics over a longer time need to be designed with manufacturability end-user needs in mind and must comply with the highest quality and regulatory standards.

  9. 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.

  10. 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.