Most have held positions within FDA and/or were senior leaders within the biopharmaceutical industry, and have played instrumental roles in crafting the policies and procedures used today. The majority of our consultants have terminal degrees in the sciences or medicine and all are hands-on professionals with an intimate knowledge of the scientific, regulatory and business challenges that must be overcome in order to bring a new product to market. Additionally, our consultants have knowledge needed for post-approval support, Phase IV commitments, and new indications for already approved new drugs/biologics.
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