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C. K. (Carolyn K.) Gund, Ph.D., Founder,
Chairman and President of PhoenixSM,
experienced in FDA regulatory matters since 1975, is well
versed in various submission processes such as GRAS, Food
Contact Substances and Infant Formula Notifications, Food,
Feed and Color Additive Petitions, 510(k)s, PMAs, INDs, DMFs,
and NADAs. Dr. Gund has worked with her clients in submitting
their applications electronically, managed expert panels,
and responded to labeling, dietary supplement matters and
general compliance problems for various regulated products.
Working with FDA in various positions gave Dr. Gund in-depth
knowledge of its procedures and policies. Her educational
background (Ph.D. in biochemistry and postdoctoral position
in neuropharmacology) provides her the analytical skills to
address many technical problems that you, as a client, face
in preparing your responses to FDA.
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