Regulatory Compliance Solutions

  1. Cleanrooms And Equipment For 503B Outsourcing Facilities 6/9/2023

    Germfree understands the unique challenges associated with 503B sterile drug compounding

    Sterile drug compounding involves preparing customized medical formulations to address individual patient needs. Key challenges include guaranteeing medication safety and efficacy, adhering to FDA regulations, and managing suitable environmental conditions during the process. Improper compounding can be hazardous, making compliance with standards like USP <797> and <800> vital. 503B providers must also follow FDA regulations, including cGMPs, for outsourcing facilities.

  2. Minimizing Uncertainty Throughout The Development Lifecycle

    Wearable technologies that allow for dosing of high-volume biologics over a longer time need to be designed with manufacturability end-user needs in mind and must comply with the highest quality and regulatory standards.

  3. Global Technical Services 10/15/2024

    From risk assessment to bio-decontamination solutions, drive continuous improvement in contamination control with tailored expert support.

  4. Pharmacovigilance 5/28/2024

    The quality of your drug safety team is of the highest importance. That’s why you need an experienced and committed partner who commands the regulatory landscape with confidence. Our global and scalable safety solutions are designed to be efficient, affordable, and fully compliant, giving you flexibility and peace of mind in a complex clinical environment.

  5. Quantitative Analysis With The SCIEX Triple Quad™ 5500+ System 6/19/2023

    The SCIEX Triple Quad™ 5500+ system is engineered to deliver best-in-class quantitative analysis.

    The best just got better. The SCIEX Triple Quad™ 5500+ system is equipped to conquer your laboratory’s most complex workflows and opportunities. With this LC-MS/MS system, you have the sensitivity and performance to meet analytical and regulatory demands for low-level trace detection with ease.

  6. Batch Execution Module 3/7/2025

    Ecolab’s Batch Execution Module enhances pharmaceutical manufacturing with AI-driven scheduling, real-time monitoring, automated compliance checks, and proactive alerts to improve efficiency, quality, and regulatory adherence.

  7. Complaints and Deviations 4/27/2022

    At Kymanox, we have extensive experience eliminating complaint backlogs and identifying appropriate corrective actions. We work to proactively identify roadblocks and bottlenecks that slow down progress. We collaborate with your Device, Pharma, Quality, and Manufacturing teams to ensure investigations are thorough and accurate by identifying patterns and trends to streamline the investigation process.

  8. 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.

     

  9. Class 2 Biological Safety Cabinet: Type B2 8/29/2023

    The Class 2, Type B2 Laminar Flow Biosafety Cabinet provides a high degree of localized protection from particulate and aerosol hazards. The work area is continuously bathed with laminar flow ISO 5/Class 100 HEPA-filtered air while creating a negative pressure airflow into the cabinet to provide user protection.

  10. R&D And Analytical Services 3/4/2022

    Our team of analytical experts provides experience, efficiency, and technical proficiency in the development/validation of analytical methodology and GMP testing support for your project.