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Bruce Mackler Ph.D., J.D.
Bruce F. Mackler is a senior advisor in FDA matters and FDA due diligence issues to financial/investment groups and companies. He is effective in developing and implementing FDA strategies for product approval of biologics, drugs and medical devices in the US and the global market place. Bruce couples his scientific knowledge (M.S., Ph.D. Immunology) with practical, hands-on regulatory experience of 27 years of FDA legal work on traditional and biotechnology derived products. He continues to provide FDA advice to US and European financial (venture capital and royal fund investment groups and stock analyst) groups, directly to biomedical product companies and is available to assist you. His grasp of the technical and FDA issues is augmented by his understanding of the commercial realities facing biomedical companies and products in the marketplace including the intended use claims, reimbursement and cost of goods. His business acumen is on his work experience including that in a family business in the packaging field, operationally in organizing and managing multidiscipline research laboratories and as management of several biomedical commercial entities. He has a proven record of accomplishments in moving technology from the laboratory into animal and human testing and FDA marketing submissions.

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