Services


DOC Inc. provides a wide range of services relevant to products regulated by the FDA Center for Veterinary Medicine. The following is a list of the most common tasks.
  • Determine the regulatory category (drug, food additive, device, biologic, or “other”) of investigational products for use in animals
  • Strategic and product development planning
  • Provide training about the FDA animal drug approval process
  • Organize meetings and negotiate with FDA
  • Draft and edit documents for FDA review
  • Assist in regulatory activities associated with product approval for
    • New Animal Drug Applications (NADA) and
    • Abbreviated New Animal Drug Applications (ANADA - generic animal drugs)
  • Assist clients in choosing and working with Contract Research Organizations to run toxicology, target animal safety, and effectiveness studies
  • Monitor safety (GLP) and effectiveness (GCP) studies
  • US Agent for foreign companies