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    PHCbi LabSVIFT® IoT Lab Management Solution

    PHCbi brand’s LabSVIFT® IoT lab management solution is designed to provide real-time visibility and control of laboratory equipment and environments across single or multiple facilities. This cloud-based platform enables centralized monitoring, customizable alerts, and secure data access via a web-based dashboard. The new health check* function continuously evaluates equipment performance, identifies irregularities, and provides recommended corrective actions to maintain optimal operation. The system supports FDA 21 CFR Part 11 compliance and is compatible with select PHCbi and third-party devices. *health check function compatibility varies by model

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    Compaction Simulation / Emulation

    Building on the capabilities of the NP-RD10A benchtop tablet press (discussed in our previous article on USP <1062>), our services are further enhanced by the integration of the Presster™ compaction emulator. This state-of-the-art tool is designed to replicate the compaction dynamics of production tablet presses in a laboratory setting. It allows for tangible fine-tuning of the compression cycle, providing an accurate depiction of how a tablting formulation will behave under commercial manufacturing conditions. Using the Presster, Natoli Scientific can simulate full-scale production, permitting us to forecast problems before they escalate to costly production delays. Our experts can optimize the tablet design for our clients, ensuring a smooth transition from laboratory to production while adhering to the rigorous standards set by the industry including the current USP <1062> chapter.

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    Combat Nitrosamine Challenges With Comprehensive Analytical Solutions

    As consumer safety becomes increasingly vital, the analysis of nitrosamine impurities in pharmaceuticals is critical. Classified as probable human carcinogens, nitrosamines pose significant health risks, prompting regulatory bodies like the U.S. Food and Drug Administration (FDA), Health Cananda and the European Food Safety Authority (EFSA) to implement strict guidelines.

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    Medical Writing For Clinical Trials

    For successful regulatory outcomes, we provide quality medical writing services for clinical trial documents, safety updates, and marketing applications.

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    Should You Digitalize Your CQV Process?

    Legacy paper trails are a compliance nightmare.

    Missing documents, illegible handwriting, and inconsistent data leave you scrambling and vulnerable during audits. Digital CQV captures data and objective evidence in real time, ensuring a crystal-clear audit trail with time-stamped entries and electronic signatures that meet 21 CFR Part 11 requirements.

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