Regulatory Compliance Solutions

  1. SAP Regulatory Compliance 4/28/2022

    The Kymanox Intelligent Enterprise Team is an international provider of ERP compliance (e.g., FDA, EMA) solutions for life sciences. As pragmatic client advocates, we offer a patient-centric, risk-based approach balanced with both regulatory requirements and business needs.

  2. 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.

  3. Regulatory Information Management System (RIMS) Software 8/23/2021

    A clear path to global regulatory submissions.

  4. 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.

  5. Corrective Action Preventive Action (CAPA) Software For Life Sciences 8/23/2021

    Quality events are inevitable, no matter how much care is taken to avoid them. As a critical part of a quality management system, CAPA identifies and addresses the root causes of high-risk quality issues and helps to limit the resulting business impact, both immediately and in the future.

  6. As Biopharma Advances, So Must Our Data Integrity 10/4/2024

    Therapies are more complex, tailored, and varied than ever, and the associated amount of data is growing – which requires a new level of attention to detail.

  7. 21 CFR Part 11 Compliance Checklist For A Universal Pump 5/7/2024

    This checklist provides a detailed look at the requirements of 21 CFR Part 11 and highlights how the Sterisart® Universal | Gen 4 - Advanced supports your efforts to meet these regulatory demands.

  8. Good Clinical Practice 4/28/2022

    When implementing quality decisions and compliance solutions for your Good Clinical Practice (GCP) investigations, Kymanox draws on its extensive life science and translational medicine experience. We prioritize patient safety and utilize expert project management to ensure scope, schedule, budget, and risk are tracked and communicated throughout your clinical programs.

  9. 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.

  10. 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.