Regulatory Compliance Solutions

  1. 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.

  2. 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.

  3. 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.

     

  4. Rapid Sterility Testing: Actionable Results In Less Than 5 Hours 6/20/2024

    Use a real-time PCR (qPCR) solution for testing cell therapy products that provides sterility results in less than 5 hours.

  5. 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.

  6. 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.

  7. Highly Potent And Complex API Contract Manufacturing 4/23/2024

    Equipped with a diverse array of scales, our seasoned experts possess the finesse and acumen necessary to tackle even the most intricate and potent API projects.

  8. Remote Cleanroom Microbial Air Sampler (Annex 1-Compliant) 12/1/2022

    The MiniCapt® Pro Remote Microbial Air Sampler from Particle Measuring Systems (PMS) incorporates the latest viable cleanroom monitoring technologies into one instrument to customize cleanroom and aseptic area microbial monitoring according to ISO Class 5/7, GMP Grade A/B, and for use in background areas monitored by a Facility Monitoring System (FMS).

  9. 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.

  10. Partner With The Experts In Annex 1 10/15/2024

    Prepare for Annex 1 compliance with expert-led support in contamination control, featuring solutions that cover risk assessment, validation, and training to ensure cleanroom safety and compliance.