Healthcare

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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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    Color CMOS Cameras For Life Science Research Experts

    Color CMOS Camera K5C

    The powerful, focused research choice

    When small details make all the difference, the K5C microscope camera gives you the power to find them. The color CMOS camera of choice for the materials and life science research expert, the K5C helps you to distinguish, study and document the small details in high resolution.

    The K5C enables you to capture high-resolution images at any magnification level due to its 20 MP CMOS sensor. You’ll get insights and results for live images fast, thanks to the frame rate of 32 fps, helping you use speed to your imaging advantage.

  • GettyImages-1414481878 clinical trial, patient, diversity
    How Trial Compass Is Solving Psychiatric Trial Enrollment

    Psychiatric trials have long been among the most difficult to enroll. From treatment-resistant depression (TRD) and PTSD to cognitive and neuro disorders, sponsors are facing the same challenges over and over again:

    • Narrow I/E criteria that don’t translate into real-world patients
    • Sites with limited behavioral health infrastructure
    • Lack of patient trust and trial awareness in psychiatric populations
    • Professional patients
    • Rating scales aren’t used in clinical practices

    But what if recruitment didn’t have to start with a gamble?

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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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    FDA Regulatory Consulting

    Our goal is to help your business succeed by working with you to streamline the FDA regulatory process. ProPharma’s team of science- based regulatory consultants commands an unparalleled breadth and depth of knowledge pertaining to FDA’s regulatory framework and can work with you to accomplish your business objectives.

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