Halloran Solutions

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. Technology And Data Solutions 10/30/2023

    Gain insight into a novel perspective that's driving life science organizations toward innovation, efficiency, and groundbreaking discoveries.

  7. Successful Management Facilitates Marketing Application Prep 10/30/2023

    See how this small clinical-stage biotech team was able to adopt greater responsibility and accountability and embrace the criticality of structure and timelines through evaluation and mentorship.

  8. Fast-Tracking Your Product Development With An IDP 10/30/2023

    Explore how a customized Integrated Development Plan assisted in the removal of guesswork and obstacles from a startup's development roadmap, enabling it to move with speed and remain competitive.

  9. A Successful Pre-IND Enabling Next Stage Of Development 10/30/2023

    Confronted with challenges, unearth how after receiving regulatory consulting services, this biotech was able to evaluate deficiencies in its development program, augment leadership and technical expertise in its application review, and more.

  10. Effective Clinical Evaluation Preparation Enables EU MDR Compliance 10/30/2023

    Uncover how one company was able to ensure that its European products remained on the market through outsourced preparation of high-quality Clinical Evaluation Reports (CERs) for submission to Notified Bodies.