Regulatory Compliance Solutions

  1. Quality Assurance + Compliance 4/27/2022

    Kymanox has a diverse background covering biotechnology, pharmaceuticals, medical devices, in vitro diagnostics, and combination products. Turnkey solutions are available to support your objectives as you progress from early stage clinical development through commercialization and post-commercialization. Our experts can support specific projects or augment staffing for defined periods of time.

  2. Biopharma Manufacturing Process Data Made Simple 9/6/2023

    PIMS makes BioPharma manufacturing process data accessible, transferable and meaningful

  3. Good Laboratory Practice 4/28/2022

    Kymanox uses the principle of Ideal Knowledge Transfer™ (IKT) to help your organization address the challenges of complying with Good Laboratory Practice (GLP) regulations while increasing confidence in your scientific research. The Kymanox team has a diverse background and proven past performance in lab bench research, analytical science, in vitro diagnostics, quality control, and translational medicine.

  4. Out Of Specification (OOS) Software For Life Sciences 8/23/2021

    The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.

  5. RegOps Services To Streamline Regulatory Submissions 5/28/2024

    Our RegOps team offers document-level publishing or management of the entire regulatory submission process. Coupled with our electronic document management system (Veeva), we can oversee all technical aspects for submission of your dossier (eg, eCTD document granularity, utilization of content templates, document formatting, hyperlinking, bookmarks, navigation, publishing, and redaction services).

  6. 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.

  7. 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.

  8. Transformative Cell Line Development Workflow ClonePix 2 Mammalian Colony Picker 6/21/2023

    A transformative cell line development workflow with automated clone screening and optional monoclonality assurance on day 0*

    The ClonePix® 2 Mammalian Colony Picker​ is a complete solution for the automated screening and objective selection of high-value clones across diverse cell types.

    The ClonePix® 2 Mammalian Colony Picker is a fully automated system for selecting high-value clones used in antibody discovery and cell line development. Screen more clones in less time with monoclonal verification on day zero, then screen and identify for highest producers in weeks, not months.

  9. 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.

  10. Combination Products 4/28/2022

    Kymanox provides turnkey services to bring your product from concept to commercialization — and helps keep your product on the market. Kymanox has expertise in injectables (e.g., syringes, mechanical and electromechanical autoinjectors, wearable injectors, dual chamber systems, reconstitution systems), respiratory combination products (e.g., metered dose inhalers, dry powder inhalers, nasal sprays), and in ocular products (e.g., multi-dose containers, single-use injectables).