The Gnomon Group, LLC
Regulatory Affairs Consulting
About Us
Mike Dalton
Pharm.D., has worked in the pharmaceutical industry for over 25 years in large companies, small startups and contract research organizations. During his career, which began at Burroughs Wellcome, Research Triangle Park, North Carolina, USA, Mike has been involved in regulatory strategy, drug safety, NDA approvals for NCEs and many other important supplemental NDAs, and has assisted in the filing of numerous INDs, serving as the FDA contact person.
Pharm.D., has worked in the pharmaceutical industry for over 25 years in large companies, small startups and contract research organizations. During his career, which began at Burroughs Wellcome, Research Triangle Park, North Carolina, USA, Mike has been involved in regulatory strategy, drug safety, NDA approvals for NCEs and many other important supplemental NDAs, and has assisted in the filing of numerous INDs, serving as the FDA contact person.
Tom Shumaker
M.S., has over 30 years of experience in the pharmaceutical industry, half of those in regulatory affairs. He worked at Burroughs Wellcome in Research Triangle Park, North Carolina, USA, and then for Glaxo SmithKline, Triangle Pharmaceuticals, Gilead Sciences and others. Tom's broad-based experience includes regulatory strategy, FDA liaison, submissions management, advertising and promotion review, and establishing and managing regulatory files.
M.S., has over 30 years of experience in the pharmaceutical industry, half of those in regulatory affairs. He worked at Burroughs Wellcome in Research Triangle Park, North Carolina, USA, and then for Glaxo SmithKline, Triangle Pharmaceuticals, Gilead Sciences and others. Tom's broad-based experience includes regulatory strategy, FDA liaison, submissions management, advertising and promotion review, and establishing and managing regulatory files.
