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From startups to global organizations, we have your solutions.

Halloran has the people to get you where you need to go.

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When you’re starting a biotech or device program, everything is urgent. The pace is demanding, the challenges intimidating, and decisions have far-reaching implications.

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Functioning in an organization spanning international borders and clinical regulatory environments means overcoming obstacles, and doing so inside the boundaries of the big picture.

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The Best Talent in the Industry.

A company with a culture of great ideas and close collaboration and passion to always do what is right for our clients. We have been assembling the strongest life science consulting team in the business for more than two decades. Attracting the best people is a product of thought leadership, but also of culture.

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  • Regulatory Consulting
  • Halloran Clinical Quality Assurance Consulting team
  • Halloran FDA Audit and SOP Expert Consulting team

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Overcoming FDA clinical regulatory hurdles, diagnosing organizational dysfunction, addressing quality issues, adverse event preparedness, evaluating potential investments, or even just filling in knowledge gaps – all of our capabilities become yours.

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7 Steps to a Successful First Date with FDA

Featured Post from Our Thinking

“His palms are sweaty, knees weak, arms are heavy…” Was Eminem talking about his first encounter with the Center for Devices and Radiological Health (CDRH) at FDA? Why does the anticipation of a first “date” with CDRH send your heart into overdrive?   And what do you need to do to prepare adequately so you don’t feel like a hormonal teenager about to go on a first date? Here is what you can you do to ensure success on your “first date” with CDRH – from asking them out to that awkward goodbye. First of all, ask yourself - do I really want to date CDRH? Yes! It’s free and easy. And you can get input into any aspect of your product life cycle, but to make a good impression on that date, you really need to be prepared so you are well regarded from the first interactions. How should you ask them out? Follow the CDRH pre-submission guidance. If you do, you are pretty much guaranteed that they will say yes. Meet the requirements outlined in the pre-submission guidance for a high quality submission (i.e., ensure that it’s organized, clear and concise, and you’ve identified your questions) and ask for a face-to-face meeting, a teleconference, or just a written response. What are you going to talk about? Identify your critical issues – these can vary depending on where you are in your product development cycle. Get early input from all of the appropriate stakeholders and plan to meet regularly with your team. Questions can range from those...

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Upcoming Events

  • Oct092015
    ACRP Advanced GCP: Assessing Compliance Risk

    Please join Halloran when Senior Consultant, Lydia Dyett, teaches a full-day course with the Association of Clinical Research Professionals on…

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  • Oct222015
    How to Build Your Organization in an Outsourced Model – New England Clinical Operations Executive Breakfast

    Join us for our New England Clinical Operations Executive Breakfast focusing on How to Build Your Organization in an Outsourced Model on…

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  • Oct232015
    CWE Women Business Leaders Conference

    Join Halloran at the Center for Women & Enterprise Women Business Leaders Conference October 22 - 23, 2015 when Laurie…

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