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Regulatory

Vedic Lifesciences can prepare or support a health claim approval application or other such submissions to regulatory agencies such as US Food and Drug Administration (FDA), Federal Trade Commission (FTC), Health Canada, European Food Safety Authority (EFSA), Therapeutic Goods Administration(TGA), etc.If you are making any of these submissions then Vedic may improve your chances of approvals.

  • Dietary supplement label claims compliant to FTC and other guidelines
  • Health claim under Article 13.5 or 14 of Regulation (EC) No 1924/2006
  • Substantiation of nutrition and health claims in several other countries
  • Natural Product Number (NPN) from Health Canada
  • OTC/IND/NDA for a Botanical Drug Product
  • GRAS Affirmations
  • Medical Foods
  • Clinical Trial Application to DCGI
  • 505(b)(2) approvals from US FDA