Regulatory Compliance Solutions

  1. Class 2 Biological Safety Cabinet 8/29/2023

    The Class 2, Type A2 Laminar Flow Biosafety Cabinet provides a high degree of localized protection from particulate and aerosol hazards. The work area of the biological safety cabinet is continuously bathed with laminar flow ISO 5 HEPA-filtered air to protect the product from contamination while an inward airflow protects the user. Approximately 70% of the air from each cycle is recirculated through the supply HEPA filter while the remaining air is discharged from the biosafety cabinet through the exhaust HEPA filter. These biosafety cabinets eliminate cross-contamination and the accidental release of carcinogenic aerosols and drugs to the outside environment.

  2. Compliance & Regulatory Programs For Drug Manufacturing 10/25/2024

    Our experts implement proven, streamlined processes that maintain compliance, quality standards, and efficiency while also managing costs, schedules, and scope.

     

  3. The Industrial DataOps Solution For Industry 4.0 1/22/2024

    HighByte Intelligence Hub is a DataOps software solution purpose-built for industrial data. The Intelligence Hub enables manufacturers to securely connect, model, condition, and flow valuable industrial data to and from IT systems without writing or maintaining code. The software is deployed at the Edge to merge real-time, transactional, and time-series data into a single payload for consuming applications.

    With the Intelligence Hub, users can speed system integration time, rapidly leverage contextualized data for analytics, AI, and ML applications, and govern data standards across the enterprise. HighByte Intelligence Hub provides the critical data infrastructure for Pharma 4.0.

  4. Strategic Staffing Solutions 4/28/2022

    Our ready-now resources cover a broad range of scientific, engineering, and compliance disciplines supporting the entire life cycle of biopharmaceutical and combination product (e.g., biologic + device) development and operations. We empower resources in staffing roles with direct access to the entire Kymanox organization, including access to and oversight from our wide array of Life Science leaders and Subject Matter Experts (SMEs).

  5. Dynamic Vapor Sorption Analyzer 4/17/2023

    Discover a system for advanced engineering and attention to detail that provides enhancements in every aspect of DVS technology as well as a new level of user experience.

  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. Axon Digidata 1550B Low-Noise Data Acquisition System Plus HumSilencer 6/20/2023

    High-resolution, low-noise digitizer with 50/60 Hz line-frequency noise elimination.

  8. 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.

  9. Culture Media For Biological Indicators 3/1/2024

    Soybean Casein Digest Broth is the recommended media for use with Biological Indicators. The use of another media may detrimentally affect the outgrowth of spores.

  10. Electronic Batch Records (EBR) Software For Drug Manufacturing 10/23/2024

    Ensure compliance and improve efficiency by automating your paper-based systems with an integrated EBR system, like MasterControl Manufacturing Excellence.