Without standardizing a product for its Quality there is no meaning to do any further safety or efficacy studies. Only when the herbal product can be guaranteed to be identical batch after batch and stable on the shelf, should any animal or human study be undertaken. Safety studies should take precedence over efficacy studies even for herbal products that are generally perceived as safe. Toxicology also helps in identifying possible therapeutic doses that can be explored in subsequent efficacy studies. We propose to conduct the first human studies earlier than usual in conventional drug development. We propose long-term toxicity studies after the human proof of concept study.

We believe that this approach can get Natural Products on the market faster at lower costs to the sponsor company. We strive to give our clients what they do not and cannot get from a large CRO or for that matter any drug CRO. We believe in personalized attention and timely completion of project at reasonable cost.

Herbal Product development strategies and sequence may immensely differ from product to product and company to company but our suggested plan is depicted here.

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