Regulatory Solutions

  1. iCELLis™ Single-Use Fixed-Bed Bioreactor Systems 11/6/2025

    The iCELLis™ bioreactor system is an automated, single-use, fixed-bed bioreactor that provides excellent cell growth conditions for adherent cells.

  2. 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.

  3. 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.

  4. Global Experts In Nanotechnology And Drug Particle Engineering 3/9/2023

    Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."

  5. Single-Use Supply Chain: The Distinct Advantage Of The Advanced Central Management System (ACMS) 6/6/2022

    This fully validated solution to support a Quality by Design approach to single-use assembly design and production. It ensures the delivery of high-quality, fit-for-purpose, single-use systems with strong documentation packages.

  6. Palltronic® Flowstar V Integrity Test Instrument 3/10/2022

    Filter integrity testing reaches a whole new level with the Palltronic Flowstar V featuring higher safety margins with a plug-and-play network integration.

  7. 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.

  8. GxP Compliance Software For Life Sciences (21 CFR Part 11) 5/4/2021

    Accelerated GxP and 21 CFR Part 11 compliance without disrupting your existing workflows.

  9. GxP Document Management For Life Sciences Guide 12/7/2020

    Choosing the right document management platform comes with daunting responsibility: compliance, usability, and adoption to name a few. We created this Buyer’s Guide to provide you with a tangible framework to evaluate varied solutions and, ultimately, identify one or more that meet your specific use case.

  10. Control GMP Content And Prevent Revenue Loss In Life Sciences Manufacturing 11/21/2012

    Life sciences organizations face more pressure than ever to run efficient, uninterrupted manufacturing production at the lowest possible cost. To stay compliant with government regulations, quality and manufacturing organizations must precisely follow Good Manufacturing Practices (GMP) standardized processes and maintain an associated document control process that adheres to those requirements.