CRO Service
Botanical Drug pre-Clinical
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qualitative description of plant products
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quantitative description of each drug substance: mass balance test, test for residual pesticides, elemental impurities, residual solvents, ...
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HPLC or GC profiling of botanical drug products
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develop drug product quality control methods and standards
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animal safety test
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stability test
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extensive medical and toxicological literature review
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blood levels of active constituents
pre-IND Development and FDA Submission
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develop pre-IND briefing document package
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request FDA pre-IND meeting
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submit pre-IND package
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attend FDA pre-IND meeting
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address any gaps
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obtain botanical drug IND#
Botanical Drug Phase I Development
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develop phase-I clinical study protocol
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identify, select, and manage a clinical trial company to implement the Phase I study protocol
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analyzing data and complete phase-I FDA report
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maintain dialogues with US FDA till a final decision is made for Phase-I

Botanical Drug Phase II (a,b) Development
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develop clinical study protocol and submit to FDA
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identify, select, and manage a clinical trial company to implement the study protocol
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conduct data analysis, develop study report, and submit to FDA
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discuss and interact with FDA till a final decision is made

Out-licensing of Phase I and II approved products
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represent sponsors to engage big pharma companies
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conduct road shows for drug products
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coordinate and negotiate licensing terms

Botanical Drug Phase III Development
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develop clinical study protocol and submit to FDA
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identify, select, and manage a clinical trial company to implement the study protocol
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conduct data analysis, develop study report, and submit to FDA
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discuss and interact with FDA till a final decision is made

GMP Service
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GMP facility design and FDA regulatory filing
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GLP laboratory design and FDA regulatory filing
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service all levels of US FDA GMP
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Select and manage construction companines to execute GMP / GLP specifications
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full service till receiving FDA permits

Strategic Alliance Service
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Connecting entities cross the global for botanical drug development
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Connecting in-licensing and out-licensing entities
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Identifying plant products for clients' specific needs of disease areas
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Connecting manufactures and investors for botanical drug development
