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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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Organizational Solutions

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

Find the best solutions for you.

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

  • May132016
    Convergence Forum East 2016

    Halloran is pleased to sponsor and support 2016's Convergence Forum East. The Convergence Forum brings together high-level healthcare players to…

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  • May192016
    eTMF: The Hidden Treasure – New England Clinical Operations Breakfast

    Every life science company faces two basic dilemmas as they move through clinical development creating the story of the program for future…

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  • May262016
    3rd Annual Pharmacovigilance & Risk Management Strategies Summit

    This 2-day event will closely follow the changing landscape of the pharmacovigilance legislation and bring together leading experts who will…

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