speaker-info

Greg Dombal

Chief Operating Officer, Halloran Consulting Group

Greg joined Halloran Consulting Group in 2007.  He focuses on helping emerging companies navigate challenges in product development while establishing appropriate clinical, regulatory, and compliance structures. Greg represents clients to worldwide regulatory agencies and routinely functions as an on-demand head of regulatory, clinical, or development.

Greg pairs over 25 years of experience in worldwide regulatory affairs, quality assurance and clinical development with a willingness to challenge conventional, conservative approaches and find the best solution for each company and their products.  Before joining Halloran, Greg was responsible for the regulatory, quality assurance, and clinical groups at ArQule. At its peak, the programs he was responsible for encompassed 17 clinical studies with annual budgets in excess of $25 million.

Over his career, Greg has successfully filed over 45 clinical trial applications (IND, IDE or equivalent), attended over 75 regulatory agency meetings, presented to multiple Advisory Committees and helped companies respond to Warning Letters, 522 Orders, and Clinical Hold notices.  He has obtained Orphan Drug designation and/or Fast Track designation for fifteen individual products, successfully negotiated multiple Special Protocol Agreements, and has extensive involvement with NDA/MAA submissions resulting in multiple product approvals.

Greg holds a Bachelor of Science in biology from the University of North Carolina at Chapel Hill.  He is also a certified PROSCI change management professional from Colorado State University.  He is involved with many non-profit organizations; as an advisor to the Fit Girls Foundation a 501(c)(3) building strong, brave and fit young women; as a past president of Marblehead Youth Baseball, and was a founding board member of the TriROK Foundation a 501(c)(3) dedicated to eliminating childhood obesity.

My Sessions

Regulatory Strategy Based on Novel Pathways

Device and diagnostic companies map the path to market, usually seeking the fastest, least burdensome path to market.  Several regulatory pathways exist for medical devices – each with their own challenges and each can present opportunities for managing the life cycle of your product.  Please join our panelists as they discuss the development of a […]

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