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Loren Miller, Ph.D. |
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Services offered: Strategic consulting in regulatory and clinical areas including regulatory strategy, FDA interactions and meetings, clinical compliance, development plans and project management. Regulatory and clinical experience: Dr. Miller has over 25 years experience in the pharmaceutical industry, having worked in both the large pharmaceutical and CRO environment in clinical research and regulatory departments. He has served on the Board of Directors of the Drug Information Association and the North Carolina Biotechnology Center and has received the “Distinguished Service Award” from the DIA. He has over 60 publications and has conducted over 50 presentations at scientific and regulatory meetings. His industry experience includes work and management on over 100 IND and NDA submissions and over 50 FDA meetings. In addition, he has managed large staffs in the areas of Drug Safety, Regulatory Affairs, Medical Writing, and Program Management. |
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The BioPharm Team |
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