Halloran Consulting Group is a life science consulting firm that provides strategic regulatory, quality, clinical, and organizational support to industry leaders and startup visionaries in the pharmaceutical, biotechnology, and medical device sectors. Our consultants are subject matter experts who deliver a tailored approach to each engagement, successfully propelling our clients to their next inflection point. We connect clients with our trusted industry partners to drive operational excellence and innovation throughout their organizations. Our aim is to support our clients, and the patients they serve.
Regulatory: Our regulatory services span every stage of development, from the preparation of early regulatory strategies for preclinical interactions to commercial and post-marketing activities. We guide our clients through early-stage strategic planning to global health authority meetings and post approval changes. Our regulatory advisors help guide development and submission strategies, accelerated regulatory pathways, and when needed, we’ll even stand in as our clients’ regulatory team to get them over any hurdle along the way.
Clinical: Our clinical development and operational services span clinical program leadership, clinical project management, clinical organizational leadership, and people development and coaching. From strategic development plans and study design to vendor selection and oversight, we help our clients map the path, identify and mitigate risks, and keep their clinical programs on track.
Quality: We help our clients achieve their quality policies and best practices. We perform organizational quality assessments, audits, and inspection readiness activities to evaluate our clients’ adherence to procedures and regulatory requirements and to determine how effectively the QMS is implemented. We guide our clients through harmonization plans to help them become streamlined and fit-for-purpose quality organizations.
Strategy & Program Leadership: Our Halloran experts with deep expertise in science and advanced knowledge of the development and commercialization lifecycle, lead our clients thru their most challenging business goals to achieve their greatest chance of success. Whether we are leading new company formation with a fully integrated development team at the ready, enabling investments with robust diligence or market assessments, or providing accelerated, durable development strategies for enhanced company value creation, we are your development partner.
Women-owned/operated
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Contact
Lori Kaiser
Director of Business Development
240.417.4495
[email protected]Mark Hagerty
Business Development Specialist
617.307.7323
[email protected]3040 Science Park Road
San Diego, CA 92121
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