Halloran Solutions

  1. GxP Quality Assessment And Remediation 9/16/2024

    Ensure regulatory compliance and foster continuous improvement through the use of comprehensive GxP quality assessment and remediation services.

  2. Regulatory Special Designations 8/16/2024

    Discover how securing an FDA special designation can accelerate your drug development process and bring life-saving therapies to market faster.

  3. Investigational New Drug Application Support 7/24/2024

    When faced with industry pressures, companies turn to Halloran for essential support in their initial investigational applications. We provide a roadmap to ensure your product's market plan is grounded in expert guidance.

  4. GxP Data Integrity: Assessment, Readiness, And Compliance 7/24/2024

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

  5. Why Regulatory CMC Strategy Is Crucial To Drug Development Projects 7/12/2024

    Our goal is to provide comprehensive Reg CMC strategic advising that not only aligns with regulatory expectations but also enhances the efficiency and success of your drug development efforts.

  6. Inspection Readiness 6/18/2024

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

  7. Strategic Advising For Lifecycle Development: Navigating Complexity With Precision 5/15/2024

    Discover tailored strategies crafted to align with your company's goals and objectives that draw upon extensive past, present, and ongoing experiences to drive success at each pivotal stage of your journey.

  8. 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.

  9. 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.

  10. 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.