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"Modern development of drugs and other therapies is among the most complex of all scientific endeavors. The involvement of numerous disciplines, huge volumes of data, interdependent decision making among professionals in different organizations, and demanding economic realities all contribute to this complexity."
Alexander Fleming, A Task and Problem Focused Approach to the Development and Regulation of Drugs
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Home : Services : Contracted : Regulatory Strategy & Communication
Regulatory Strategy & Communication
Kinexum President and CEO, Dr. Alexander Fleming brings a deep understanding of the complex environments of therapeutic development, evaluation, and regulation. His unique perspective is formed by his extensive experience at the FDA and serving in private industry as chief scientific officer for a clinical research organization, chief medical officer for a technology development company, and numerous appointments to scientific advisory boards. He knows what it is like to sit on both sides of the table of therapeutic and technology development and the regulatory approval process.
Kinexum is a good choice when the shortest, most optimized pathway to product approval is demanded or when innovative solutions are sought when faced with regulatory challenges. Dr. Fleming and his colleagues at Kinexum, with the support of a network of experts with experience at FDA or other regulatory agencies, provide such guidance with keen understanding of the landscape and risks involved.
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"A global perspective on the regulatory approval process can significantly reduce the time to market. Experience with global regulatory agencies offers opportunities for innovation."
-- Dr. Munaf Ali
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