Consultants Specializing in Regulatory Affairs for FDA Compliance

Smith Associates, FDA Consultants

Consultants Specializing in Regulatory Affairs for FDA Compliance

Since 1994, under the direction of E J Smith, President, Smith Associates has specialized in regulatory services for the medical manufacturers of medical devices, in vitro diagnostics, cosmetics, biologics and blood. We have recently added Drug Monograph consulting to our portfolio.

Smith Associates has extensive experience in all aspects of the regulatory processes of 510(k), 513(g), Pre-IDE, IDEs and PMA/BLA submissions. Our successes with 510(k)s, PMA, and IDEs, are summarized in our 510/IDE/PMA.

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