Regulatory Solutions

  1. Orphan Drug Designations 10/30/2023

    Get unique insights into current expectations set by the U.S. Food and Drug Administration and the European Union, as well as distinctions between Orphan Drug Designation (ODD) criteria for the two entities.

  2. New Insights Into FDA Meetings 10/30/2023

    Having led or supported approximately 22 formal meetings with the FDA annually, discover how Halloran has helped companies craft regulatory strategies, prepare documentation, and orchestrate FDA discussions.

  3. GxP Auditing, Compliance, And Specialized Consulting 10/26/2023

    Advarra’s experts can work directly with your team to provide global consulting and evaluation services related to research, clinical quality assurance, regulatory compliance, and human research protection.

  4. IRB Solutions To Empower Better Research Programs 10/18/2023

    Irrespective of a project's scale, therapeutic focus, or the size of its investigative team, discover how Advarra works to stand as a trusted partner in conducting efficient and responsible research.

  5. eISF: Industry Standard eRegulatory Software For Clinical Sites 10/6/2023

    Modernize your study binder processes with Florence eBinders™, offering remote access for sponsor interactions, monitoring, and source data review.

  6. Selecting And Evaluating An eRegulatory Solution 10/6/2023

    Take advantage of this checklist for evaluating eRegulatory solutions for clinical trial offices.

  7. Think Canada: The Team Behind Your Clinical Trials 9/29/2023

    Altasciences has a bioanalytical and clinical facility in Canada. In this video, we unveil the advantages of conducting trials in Canada while introducing some of the faces that work behind the scenes on your studies.

  8. Preparing Regulatory Marketing Applications For Successful Conclusions 9/27/2023

    Preparing regulatory marketing applications to their successful conclusions is our focus.

  9. Risk-Based Monitoring 9/26/2023

    Program, country, and study managers, CRAs, clinical monitors, trial managers, clinical data managers, CROs, and others need informatics solutions that help them focus on sites in greatest need, based on risk.

  10. GMP Auditing, Compliance, And Specialized Consulting 9/26/2023

    Ready to make your research altogether better? Learn how Advarra® is assisting clients to reduce risk and ensure adherence to good manufacturing practice (GMP), good laboratory practice (GLP), and good tissue practice (GTP) standards.