Regulatory Compliance Solutions

31. The Ultimate Solution For Your Chromatographic Separations 6/30/2025

    Enhance your chromatographic performance with advanced HPS technology to improve analyte recovery, peak shape, and reproducibility for complex compounds and demanding analytical workflows.

32. Technology Transfer And Commercial Manufacturing Of Tablets And Capsules 10/30/2023

    Finding a strategic CDMO partner that will offer tailored solutions for your late phase clinical and commercial needs, mitigate risks, and bolster your supply chain is crucial for meeting project milestones on time.

33. Pharmaceutical Asset Management & Reliability Services 12/21/2020

    Asset Management & Reliability (AMR) focuses on preserving asset functions. These functions are determined by our clients’ business strategy. The focus is on producing products that conform to consumer needs in the most efficient and cost-effective manner. While conditions vary, the common factor with manufacturing process is reliability. We help our clients determine which best practices are applicable in your industry and how best to deploy them.

34. Software For Trusted And Efficient Data Recording

    Discover your digital QC companion for sterility testing and other regulated processes. Ensure full traceability and regulatory compliance with contemporaneous, automatic, and complete recording of QC testing data.

35. Increase Your Lab Effectiveness With An Automated Platform 10/29/2025

    Discover an automation platform that delivers real-time insights to cut downtime, boost throughput, and reveal inefficiencies, which helps drive smarter automation and better lab performance.

36. Software To Automate And Digitalize Data Recording Steps In QC Workflows 5/2/2023

    Explore the technicalities of the M-Trace™ Electronic Test Record Software, a solution that automizes and digitalizes all data recording steps during sterility testing and other quality control workflows.

37. Cleanrooms And Equipment For Viral Vector Drug Manufacturing 6/9/2023

    Viral vector manufacturing: key to successful gene therapy

    Viral vector manufacturing, critical to the burgeoning field of gene therapy, is revolutionizing medicine with its rapid growth and significant potential for treating genetic disorders. By adhering to stringent cleanroom requirements, including BSL-2 standards, Germfree enables the safe and efficient production of viral vectors like AAV and lentivirus. Our specialized cleanroom solutions support the continued advancement of this vital therapeutic field, shaping the future of healthcare worldwide.

38. Biological Indicator Testing: Meeting Regulatory Demands With Confidence 11/4/2024

    Explore cycle development and validation services and biological indicator testing services from an ISO-certified laboratory, registered with the FDA and DEA.

39. Optima™ XPN Ultracentrifuge 6/16/2023

    1,500 mL max rotor capacity 100,000 max RPM 802,400 x g

    Security and tracking Remote monitoring and control eXPert simulation software.

40. 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.