Regulatory Compliance Solutions

  1. AP-IS Series: Aseptic Processing Isolator Systems 7/2/2026

    The Aseptic Filling Isolator is a custom-designed cGMP Class A/ISO 5 isolator system specifically designed for batch scale pharmaceutical production of injectable products for pre-clinical and clinical trial studies.

  2. A First-Of-Its-Kind Advanced Qualification Dossier 10/29/2024

    This unique and comprehensive “On-Demand” dossier is designed to address the qualification requirements and provide all the information needed for your specific assembly in one location.

  3. Metrology Teams Collaborating With Waters 7/14/2022

    Explore how we can collaborate and customize our service types to help reduce your workload, decrease instrument downtime, and maintain quality standards to meet regulatory requirements.

  4. A Versatile Filtration Platform 3/16/2026

    Discover a versatile filtration platform offering fast flow, high throughput, and reliable sterility across cell culture workflows for efficient processing at any scale while protecting product quality.

  5. Automatic, Multiplexed Digital PCR With The QX ONE ddPCR System 6/7/2023

    The QX ONE ddPCR System is designed to deliver a precise and multiplexed digital PCR system. This system seamlessly integrates a standard ddPCR workflow of droplet generation, thermal cycling, droplet reading, and analysis into a hands-free precision platform.

  6. Instrument For Accurate Filter Integrity Testing 3/10/2022

    The Palltronic Flowstar V integrity test instrument ensures accurate filter integrity testing with a further reduction in test time, full compliance with 21 CFR Part 11, advanced automation capabilities, and simplified network integration saving the user time while improving process efficiency.

  7. Time To Embrace The Digital CPV 6/2/2026

    Automate data acquisition, monitor trends in real time, and respond to deviations proactively.

  8. Aseptic Filling Inspection Support Service 1/9/2026

    Prepare for GMP audits with confidence through expert guidance and tailored coaching. Explore how this service helps you navigate the regulatory complexities of advanced aseptic filling systems.

  9. Enterprise Maintenance Management 8/8/2025

    Streamline maintenance with a paperless platform that boosts uptime, ensures GMP compliance, and improves efficiency through automation, mobility, and KPI-driven insights.

  10. Dynabeads CD3 Depletion Prototype Supporting Solutions From Development To Delivery 4/21/2026

    Residual CD3+ cells shouldn't be the bottleneck in your allogeneic therapy workflow. This prototype achieves <0.5% residual T cells at commercial-scale processing capacity.