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Regulatory strategy for extended health claim

NHP 2.0. Additional products using branded ingredients. Improved claim High value NHP products Further differentiation. Clinical trial Extended health claim Consistent higher quality manufacturing. CRO. M6. Ingredient sourcing

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Regulatory strategy for extended health claim

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  1. NHP 2.0 Additional products using branded ingredients Improved claim High value NHP products Further differentiation Clinical trial Extended health claim Consistent higher quality manufacturing CRO M6 Ingredient sourcing Bioassay development for the standardization of ingredients Small batch test trial and final formula design Formula stability testing Branded Product/ ingredient ready for market Manufacturing of consistent quality Differentiated positioning M5 Design of formulation Safety and toxicity evaluation Efficacy testing of formulation Formula optimization Comparison with other competing products Publications Partner / Suntrition / Regulatory consultant as needed Suntrition / Biomedcore Ingredients and QC methods Selection of final formulation Potential IP M4 Design of preclinical studies for discovering relevant targets and biomarkers for successful clinical trial Formula concept IP Strategy Branded strategy M3 Partner / Suntrition / CRO Design of human clinical trial satisfying regulatory requirements M2 Refined preclinical strategy Refined product strategy Regulatory strategy for extended health claim M1

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