Regulatory Compliance Solutions

  1. Quality Auditing 4/27/2022

    The Kymanox Audit Team consists of Certified Auditors and seasoned Subject Matter Experts (SMEs) across a wide variety of disciplines with extensive expertise in preparing your company for regulatory body inspections and performing internal audits, external audits, gap assessments, and due diligence evaluations. We manage and execute CMC, clinical, laboratory, and supply chain audits around the world, including support for Pre-Approval Inspection (PAI) readiness.

  2. 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.

  3. 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.

  4. 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.

  5. Global Technical Services 10/15/2024

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

  6. Ensuring Compliance, Improving Efficiency, And Accelerating Time To Market With QMS Software 8/27/2021

    A lot of companies see quality management as a process that puts the brakes on progress. We’re here to change that. MasterControl QMS software will help you digitize and automate every step of quality management. We’ll help you eliminate the hassles, inefficiencies, and paper of your current system. Then you can get your products to market faster.

  7. Cleanrooms And Equipment For Viral Vector Drug Manufacturing 6/9/2023

    Viral vector manufacturing: key to successful gene therapy

    Viral vector manufacturing, critical to the burgeoning field of gene therapy, is revolutionizing medicine with its rapid growth and significant potential for treating genetic disorders. By adhering to stringent cleanroom requirements, including BSL-2 standards, Germfree enables the safe and efficient production of viral vectors like AAV and lentivirus. Our specialized cleanroom solutions support the continued advancement of this vital therapeutic field, shaping the future of healthcare worldwide.

  8. Single-Use Supply Chain: The Distinct Advantage Of The Advanced Central Management System (ACMS) 6/6/2022

    This fully validated solution to support a Quality by Design approach to single-use assembly design and production. It ensures the delivery of high-quality, fit-for-purpose, single-use systems with strong documentation packages.

  9. Batch Execution Module 3/7/2025

    Ecolab’s Batch Execution Module enhances pharmaceutical manufacturing with AI-driven scheduling, real-time monitoring, automated compliance checks, and proactive alerts to improve efficiency, quality, and regulatory adherence.

  10. Clinical Pharmacology Services 3/14/2025

    With over 30 years of proven experience, we provide comprehensive clinical pharmacology services, from data management and analysis to the generation of clinical study reports.