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Original Business Thinking for the Life Sciences |
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Allan M. Green, MD, PhD, JD, LLC Attorney at Law |
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The practice of Dr. Allan Green provides FDA-related regulatory, technical and business consulting on a confidential basis. We offer you additional input and resources to assist you with emergent problems or strategic planning. |
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How may we help you? |
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We advise clients on available strategies for obtaining FDA approval to manufacture, investigate and market products. We provide assistance in dealing with disputes that arise before, during or after the approval process. Client engagements include assisting in determining the requirements for IND and IDE submissions and for the human clinical trials required for marketing clearance. We assist in issues that arise in the planning, contracting, conducting and interpreting of the results of clinical trials, with the goal of optimizing the terms and conditions of marketing approvals. We assist with good clinical practice and good manufacturing practice compliance problems. .
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For more information about this service: |
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E-mail: amgreen@fdaregs.com |
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FDA regulatory Support |
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We assist in strategic planning and financing issues of emerging life sciences companies. We have assisted many life sciences companies and their investors in meeting corporate goals and dealing with unforeseen challenges. In addition, we can advise in the preparation of life sciences technology licensing and R&D agreements. For investors in FDA-regulated industry, we conduct informed, third-party due diligence assessments of plans, timelines and practices in FDA-regulated industry. |
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For more information about this service: |
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E-mail: amgreen@fdaregs.com |
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Strategic Planning |
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Complex issues in the evaluation of new technologies include intellectual property matters, competitive scientific and clinical approaches, assessment of regulatory hurdles and market opportunities |
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For more information about this service: |
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E-mail: amgreen@fdaregs.com |
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Technology Assessment |
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We provide experienced management consulting for life science enterprises. |
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For more information about this service: |
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Management Consulting |
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E-mail:amgreen@fdaregs.com |
To contact us call:1-617-447-5999 |