Business Process Management

PRODUCTS

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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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    Regulatory Sciences

    We want your product to move through the regulatory process, gaining approvals and ultimately helping patients. Using our industry leading knowledge and skills, we will meet you where you are – gaining approval: for the first in human trials, in development, at scientific advice, at the end of phase 2, or post approval. At every level, our scientific expertise and in-depth knowledge of therapeutic backgrounds have guided every client we have to a successful outcome.

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    Process Analytical Technology For In-line Bioprocess Analysis

    This easy-to-use process analytical technology device offers in-line bioprocess analysis and control with no complex modeling. Measure multiple critical parameters across media, across processes, across mammalian cell lines, across scales.

    All In-line Gain, No Modeling Pain

    MAVERICK is powered by Raman spectroscopy and a purpose-built de novo model. The de novo model is explicitly built on media chemistries and device physics, not on empirical data. It automatically interprets the spectra and quantifies process parameters enabling simultaneous measurements of glucose, lactate, and total biomass. This is achieved without the costs, complexities, and risks associated with conventional Process Analytical Technology (PAT) methods. There is no need to grapple with complex empirical models, reagents, or unreliable auto-sampling systems to implement in-line bioprocess analysis.

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    eTMF: Promising Accessibility, Compliance, And More

    Our model combines the depth and experience level of our people with effective tools and processes already in place that are designed to ensure your critical eTMF documents and content are secure, organized, readily accessible, and always in complete compliance with all relevant regulations.

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    Minimize Risk With Interactive Logbooks

    Guide operators through dynamic workflows from equipment startup to maintenance.

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