FDAregs.com is the web site of Allan M. Green, MD, PhD, JD, LLC and his associates. We offer FDA regulatory support as well as strategic business planning and independent due diligence assessment of technology and program strategy.
How We HelpWe are committed to using our experience in law and business as well as clinical medicine and scientific research to assist stakeholders in translational research - that is, moving new findings from the research bench to the clinic. With deep life science industry expertise, our goal is to provide our clients with knowledge and experience to allow more informed strategic business planning and capital investment in the life sciences sector.
We advise clients on strategies for obtaining FDA approval to manufacture, investigate and market products. We assist with any disputes before, during or after the approval process.
We provide guidance in strategic planning and financing. We have assisted many companies and their investors in meeting corporate goals and dealing with unforeseen challenges.
We assist with issues in the evaluation of new technologies, including intellectual property, competitive scientific and clinical approaches, assessment of hurdles and opportunities.
We provide experienced management consulting for life science enterprises. Our deep life science industry expertise brings clarity to the most complex approval process.