Botanical Agents can be approved as Drugs in most markets like USA and EU. The submission of an Investigational New Drug (IND) application to the competent authority is outlined under specific guidelines released by them. We have understanding of these regulations and have the expertise to prepare the files for such submissions leading to permission to conduct Human Clinical Trials. Most guidelines encourage early Phase II development of botanicals with a history of usage and with no known safety concerns.

Our partners in various markets have years of expertise in dealing with regulatory agencies like US FDA, Health Canada, UK MHRA, German BfArM, Australian TGA, etc. We can take care of all your Regulatory and Research needs towards developing and approval (NDA) of a new Botanical Drug Product (BDP) or Herbal Medicinal Product (HMP).

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