About Greg

Greg Dombal focuses on emerging companies, helping them navigate the challenges in product development while maintaining focus on their business objectives.  Whether that is establishing appropriate clinical, regulatory, and compliance structures or engaging with entrepreneurs, investors, or key opinion leaders, he is driven to make an impact on human health.

Greg pairs over 25 years of experience in worldwide regulatory, quality 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 a member of the Merck/EMD Precision Medicine Advisory Board and is a mentor for the German Accelerator for Life Sciences and EiT Health Accelerator Programs.  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.