Government

PRODUCTS

  • 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.

  • Mikart’s pharmaceutical regulatory support team offers a full range of regulatory support, from completing your entire FDA e-submission to a la carte services customized to your project’s specific demands.

  • Legacy paper trails are a compliance nightmare.

    Missing documents, illegible handwriting, and inconsistent data leave you scrambling and vulnerable during audits. Digital CQV captures data and objective evidence in real time, ensuring a crystal-clear audit trail with time-stamped entries and electronic signatures that meet 21 CFR Part 11 requirements.

  • The #1 QMS In Life Sciences Puts You in Complete Control

    MasterControl Quality Excellence is trusted by 1,100+ customers — from startups to global enterprises — to bring quality products to market faster.

    It's time to close the loop on quality—from quality event management to document management and training—and see how MasterControl quality management system can transform your business today.

  • Clinical trials are how new treatments move from the lab to the people who need them most. By joining a study, you’re not only accessing potential new therapies—you’re helping advance medicine for future generations.

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NEWS