Halloran Solutions

  1. GxP Data Integrity: Assessment, Readiness, And Compliance 4/24/2024

    Our team comprises seasoned professionals in life sciences and regulatory compliance, offering tailored solutions for your unique data integrity challenges.

  2. New Drug Applications And Biologics License Applications 4/15/2024

    Compiling a submission meeting stringent regulatory standards requires a partner who comprehends the regulatory landscape and can craft a compelling narrative aligned with FDA expectations.

  3. Trial Rescue: Leadership Approach To Propel Clinical Development 2/16/2024

    Learn how Halloran's assistance was able to improve a rare disease biotechnology company’s development and operations, communication workflow, and avoid the delay of a gene therapy trial.

  4. Regulatory Portfolio Management: From Bad To Gold 10/30/2023

    Uncover how a multiphased approach helped a small biotech to organize its programs so that it could efficiently make decisions, timely adapt to changes in strategy, and better understand current activities.

  5. Experience The Halloran Difference 10/30/2023

    By reviewing this established network of repeat customers and best-in-class partners, unearth how companies have been able to maintain effective interactions with regulatory agencies.

  6. Expertise From Concept To Commercialization 10/30/2023

    Learn how we can customize our approach for every engagement, helping clients from the pharmaceutical, medical device, and biotech spaces reach pivotal milestones with success.

  7. Regulatory Operations Support 10/30/2023

    With the right partner, learn how you can begin addressing document preparation requirements, document formatting, PDF publication, eCTD compilation, and submission needs through the FDA's Electronic Submissions Gateway (ESG).

  8. 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.

  9. 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.

  10. Inspection Readiness 10/30/2023

    Learn how your company can enable productive interactions with inspectors through Inspection Readiness (IR) gap assessments, and propel to the next phase of development.