Welcome to SDG, LLC
Advisors to the management and Boards of FDA-regulated industry.
SDG’s mission is to help FDA-regulated organizations, their investors and their Boards to accurately assess FDA regulatory risks and opportunities and to take decisive action to achieve their scientific and commercial goals.
Our group is experienced, thoughtful and motivated
<-->Our experience goes beyond “black letter” regulation with an understanding of your underlying business, scientific and clinical challenges.
Our backgrounds and experience encourage original business thinking and imaginative approaches to problem-solving.
We recognize the importance of long-term relationships in the life-sciences arena; and we strive to maintain your trust and confidence by working with the highest ethical standards.
SDG principals at a glance
Dr. Lee S. Simon
Physician and research scientist who has served as the FDA’s Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products, as well as a consultant to multiple FDA advisory committees and has extensive experience in drug development. Read more...
Dr. Allan Green
Physician, attorney, and research scientist who has represented and consulted with many U.S. and non-U.S. companies with deep experience in the development of medical imaging products, biomarkers and anti-alzheimer’s drugs. Read more...
Dr. Robert Makuch
Biostatistician who has been a collaborator and statistical consultant to many US and international governmental agencies, universities and life sciences companies covering a broad range of therapeutic indications including arthritis, cancer, cardiovascular, migraine and HIV. Read more...
Dr.Vibeke Strand
A leading consultant in clinical trial methodology, regulatory strategy and clinical studies, she has assisted in preparation of applications, briefing documents and data presentation for successful defense of NDA and BLA applications. Read more...
Dr. William Schweiterman
An internist with 10 years at the FDA in the Center for Biologics as Chief of the Medicine Branch, and then as Chief of the Immunology and Infectious Disease Branch overseeing clinical development plans for new agents for pulmonary medicine, neurology, sepsis, hepatitis, rheumatology, infectious disease, solid organ transplantation and wound-healing. Read more...