Business Process Management

PRODUCTS

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    Minimize Risk With Interactive Logbooks

    Guide operators through dynamic workflows from equipment startup to maintenance.

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    Digital Transformation Services

    Enabling organizations of all sizes to transform their business through better use of technology.

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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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    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.

WHITE PAPERS AND CASE STUDIES

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