Government

PRODUCTS

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    RegOps Services To Streamline Regulatory Submissions

    Our RegOps team offers document-level publishing or management of the entire regulatory submission process. Coupled with our electronic document management system (Veeva), we can oversee all technical aspects for submission of your dossier (eg, eCTD document granularity, utilization of content templates, document formatting, hyperlinking, bookmarks, navigation, publishing, and redaction services).

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    QTOF Mass Spectrometer For High Throughput Laboratories

    SCIEX X500R QTOF System

    This QTOF mass spectrometer is uniquely engineered and versatile to handle the demands of any high throughput laboratory. Incorporating the robustness of Turbo V ionization source along with MRMHR, the X500R QTOF System can quantify food and environmental testing samples to regulatory compliance requirements. For complete unknown screening, SWATH® acquisition detects any trace level compounds and delivers vital MS/MS data for forensic crime lab workflows.

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    Signal Management Services

    ProPharma has deep expertise across all signal detection and management activities, including validation, prioritization, and assessment using data from a wide range of sources that are relevant for signal detection for the individual product(s). We are also fully trained and experienced in the EudraVigilance Data Analysis System (EVDAS) functionality and can support MAHs to comply with their obligations for signal detection and management. We leverage our robust knowledge to select the most efficient and effective method(s) for each product that is compliant with legislative requirements.

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    Validation Doesn't Need To Bleed Time Or Money

    Reduce manual validation efforts, cut costs by up to 30%, get new products out the door faster, and enable seamless regulatory inspections.

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    An Inside Look At Cell Therapy Services And Support

    “Services” and “support.” What do those words mean in the life science manufacturing industry? The truth is, they’re quite subjective—and relative to each company. Here’s how we define services and support at Cytiva.

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