Regulatory Compliance Solutions

  1. 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.

  2. Microbiology, Environmental Monitoring, & Personnel Monitoring 4/27/2022

    At Kymanox, our risk-based approach to Microbiology, Environmental Monitoring (EM), and Personnel Monitoring (PM) ensures facilities and personnel operate in a state of control — ultimately ensuring patient safety.

  3. Highly Potent And Complex API Contract Manufacturing 4/23/2024

    Equipped with a diverse array of scales, our seasoned experts possess the finesse and acumen necessary to tackle even the most intricate and potent API projects.

  4. Proven Vial Containment That Scales From R&D To Commercial 2/20/2024

    Speed up your time to market and reduce your risk of selecting individual components that may not work well together by choosing the Ready Pack containment solution.

  5. 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.

  6. 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.

  7. Adopting Enabling Informatics Technologies To Drive Digital Transformation And Data Integrity 7/14/2022

    Learn how to transform your contract organization into a completely paperless, connected lab with our informatics solutions, which deliver robust, proven results and reduce regulatory risk.

  8. 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.

  9. Product Lifecycle Excellence Platform 8/27/2021

    Our platform is simple yet comprehensive. It’s scalable and secure. It combines our proven digital process automation, unmatched quality data management, and analytics into a single, natively connected platform. One that gives you tools to make quality a priority throughout your organization.

  10. Pharmaceutical Automation And Information Technology Services 12/21/2020

    As a company that specializes in troubleshooting complex systems and equipment, especially in regulated industries, we have gained expertise in Automation & Information Technology (IT) systems. These systems are the foundation of the manufacturing equipment and processes we have been commissioning and qualifying for over 20 years. Our teams work to deliver fully functional and compliant, mechanical and automated systems to our clients. Our expertise extends from specification, through implementation and startup, and into true process optimization.