This firm is committed to assist FDA regulated entities with quality management systems, design control efforts for existing and new products, CAPA, nonconformance and MDR remediations, response to the FDA following an inspections, Warning Letter or Consent Decree issues. The principle investigator has 24 years of investigational experience in the areas of medical device, drug manufacturing, blood bank and plasmapheresis and biomedical research monitoring, institutional review boards and clinical investigators.
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