Regulatory Compliance Solutions

  1. Quality Control 4/27/2022

    The Kymanox Quality Control (QC) team provides knowledge and expertise to ensure that QC processes and methods support a risk-based, Quality by Design (QbD) approach. Our Quality and Analytical Science experts ensure Right First Time execution and a reliable state of control.

  2. Partner With The Experts In Annex 1 10/15/2024

    Prepare for Annex 1 compliance with expert-led support in contamination control, featuring solutions that cover risk assessment, validation, and training to ensure cleanroom safety and compliance.

  3. Validation (CQV) 4/27/2022

    Kymanox caters to your specific needs to get CGxP Commissioning, Qualification, and Validation (CQV) done. Key practice areas are all-encompassing and include process, cleaning, analytical methods, facilities, clean utilities, equipment, methods, computer systems, and environmental chambers.

  4. 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.

  5. Cleanrooms And Equipment For CRISPR Drug Manufacturing 6/9/2023

    Revolutionizing Gene Editing: Germfree's Pioneering Cleanroom Solutions Propel CRISPR Manufacturing Forward

    Cleanroom requirements for CRISPR manufacturing necessitate strict adherence to particulate contamination and operational workflows, ensuring safety and product quality in this transformative field. Germfree’s expertise in providing specialized cleanroom solutions supports the effective production of CRISPR-based technologies and their delivery systems. Germfree provides application based fit-for-purpose facilities design to cater to the unique needs of this rapidly evolving sector.

  6. X-Ray Inspection Solutions For The Pharmaceutical Industry 2/6/2025

    Pharmaceutical manufacturers face many challenges, from safeguarding brand reputation and protecting consumers' welfare to complying with legislative and regulatory standards.

  7. SpectraMax M Series Microplate Readers 6/15/2023

    Configurable readers with triple-mode cuvette ports, validation tools, and compliance software.

    The SpectraMax® M Series Multi-Mode Microplate Readers measure UV and visible absorbance, fluorescence, luminescence, fluorescence polarization, TRF and HTRF.

  8. The Future Of Glass Packaging Is Here

    Review the potential of Corning Valor® Glass to optimize the fill/finish process and reduce total cost of quality as well as overall manufacturing cost.

  9. Software For Trusted And Efficient Data Recording

    Discover your digital QC companion for sterility testing and other regulated processes. Ensure full traceability and regulatory compliance with contemporaneous, automatic, and complete recording of QC testing data.

  10. Rapid Sterility Testing: Actionable Results In Less Than 5 Hours 6/20/2024

    Use a real-time PCR (qPCR) solution for testing cell therapy products that provides sterility results in less than 5 hours.