Healthcare

PRODUCTS

  • Asahi Sluri
    Streamline Your Media Preparation And Column Packing

    Streamline Your Media Preparation and Column Packing

    At Asahi Kasei Bioprocess, we understand the importance of efficient and reliable slurry preparation for successful purification processes. With that in mind, we have developed the SLURIPREP line of media management products to simplify your resin preparation and packing, specifically designed for DAC LC Columns. Our comprehensive range of accessories ensures that your column operation is seamless, efficient, and optimized for high productivity.

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    NDA Submissions 505(b)(1) Or 505(b)(2)

    There are clearly defined pathways for drug approval, and choosing the right regulatory pathway for your drug development program requires a thorough understanding of sections 505(b)(1) and 505(b)(2) of the Federal Food, Drug, and Cosmetics (FD&C) Act.

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    eCOA: Delivering High-Quality Patient Data

    Purpose-built with users at the center to make it easier and more efficient to get quality patient outcomes data for submissions and approvals.

    Collecting quality data on patient outcomes is often one of the most important parts of a clinical trial. It is also challenging, and many eCOA solutions make it feel even more difficult with complicated processes, lack of questionnaire reusability, slow set up, and difficult to use tech.

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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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    Manufacturing Execution System Consulting Services

    We support you in the process of optimally implementing complex Manufacturing Execution Systems. In addition to the creation of Master Batch Records (MBRs) and Electronic Batch Recording (EBR), including classic data acquisition and preparation, as well as all other processes that have immediate effects on the manufacturing process.

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