REGULATORY SOLUTIONS

• iCELLis™ Single-Use Fixed-Bed Bioreactor Systems

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

• 21 CFR Part 11 Compliance Checklist For A Universal Pump

  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.

• Sterility Testing For A Connected Era

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

• Global Experts In Nanotechnology And Drug Particle Engineering

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

• Single-Use Supply Chain: The Distinct Advantage Of The Advanced Central Management System (ACMS)

  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.

• Palltronic® Flowstar V Integrity Test Instrument

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

• Instrument For Accurate Filter Integrity Testing

  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.

• GxP Compliance Software For Life Sciences (21 CFR Part 11)

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

• GxP Document Management For Life Sciences Guide

  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.

• Control GMP Content And Prevent Revenue Loss In Life Sciences Manufacturing

  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.

• Cleanroom Capabilities And Expertise

  Learn how the right partner can ensure that your facilities maintain cGMP-compliance and help establish the correct testing program and parameters based on your needs.

• Drug Product Fill Finish And Formulation Solutions

  Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.

• Small Is Powerful, Small Is Green

  As the pharmaceutical industry innovates and evolves, learn more about how Nanoform can play a critical role in empowering your company's journey to net zero.

• EMC Documentum Quality Manufacturing Solution For Life Sciences

  Quality & Manufacturing organizations in Life Sciences companies are facing more pressure than ever to run efficient, uninterrupted production at the lowest possible cost, while meeting stringent safety, quality, and regulatory standards.