Allan M. Green, MD, PhD, JD, LLC
Attorney at Law
One Mifflin Place
Suite 400
Cambridge, MA 02138
FDA LAW
Strategic and Legal Counsel for Non-Profit Foundations, Hospitals and FDA-Regulated Industry
Dr. Green and his associates focus on issues faced by Non-Profit Foundations, Hospitals and FDA-regulated industry. We offer FDA regulatory support, as well as strategic planning advice and independent due diligence assessment of technology and program strategy.
We 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 planning and capital investment in the life sciences sector.
We advise clients on strategies for:
- Obtaining FDA approval to manufacture, investigate and market product
- Dealing with administrative issues that arise before, during or after the approval process
- Assisting in determining the requirements for IND and IDE submissions
- Planning human clinical trials required for marketing clearance
- Planning, contracting, conducting and interpreting of the results of clinical trials
- Optimizing the terms and conditions of marketing approvals
- Good clinical practice and good manufacturing practice compliance problems
- Preparation of life sciences technology licensing and R&D agreements
For the biomedical and medical devices industries and its investors, we conduct informed, third-party assessments of plans, timelines and practices in FDA-regulated industries.
For more information contact:
One Mifflin Place
Suite 400
Cambridge, MA 0213.
Tel: 1-617-447-5999
Mobile: 1-617-699-6565
Fax: 1-617-576-913.
Email: amgreen@fdalawboston.com