Regulatory Compliance Solutions

31. Flexible Manufacturing Solutions, Services To Meet Evolving Industry Needs 4/28/2021

    Review our full range of support services to streamline manufacturing processes through to the commercialization of aseptic and lyophilized products.

32. Simplify Microplate Data Acquisition And Analysis With SoftMax Pro Software 6/21/2023

    SoftMax® Pro Software - The most published microplate reader control and data analysis software

    Preconfigured protocols and custom assay workflows simplify microplate data acquisition and analysis

    SoftMax® Pro Software for Windows 10 is designed to provide the simplicity, flexibility and power required for advanced data analysis. It provides ready-to-run protocols, analysis algorithms, and 21 different curve fit options. Every step is optimized for data acquired from a Molecular Devices microplate reader or data imported from another source to simplify analysis and reporting. Compliance tools are available for regulated laboratories providing end-to-end chain of custody.

33. 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.

34. Analytical Method Validation 4/28/2022

    Kymanox supports pharmaceutical, biotechnology, medical device, and in vitro diagnostic device manufacturers in the validation of methods according to regulatory guidelines. We ensure phase-appropriate validation characteristics are clear for the intended application.

35. SecurityLink™ HPLC/UHPLC Fingertight Fittings 6/16/2023

    The SecurityLINK fingertight fitting system simplifies your system and column connections and provides consistent performance with torque limiting technology that prevents column damaging overtightening.

36. Human Factors Regulatory & Strategy 4/27/2022

    At Kymanox, the Human Factors Regulatory and Strategy (HURAS) team provides comprehensive support for human factors regulatory strategy and usability engineering from product conception through post-market and lifecycle management stages. Our team leverages the extensive expertise within Kymanox to deliver an integrated approach for your product development strategies and programs including Quality, Regulatory, Engineering, and Validation.

37. Sterility Testing For A Connected Era 5/7/2024

    This pump combines state-of-the-art hardware with sophisticated, user-friendly software to offer compliant, paperless documentation and reporting.

38. 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.

39. 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.

40. Computer System Validation 4/27/2022

    Kymanox has developed a suite of procedures and templates that provide a foundation for implementing a comprehensive Computer System Validation (CSV) program within a biotechnology, pharmaceutical, or medical device organization.