CRO Service

Botanical Drug pre-Clinical

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  • qualitative description of plant products

  • quantitative description of each drug substance: mass balance test, test for residual pesticides, elemental impurities, residual solvents, ...

  • HPLC or GC profiling of botanical drug products

  • develop drug product quality control methods and standards

  • animal safety test

  • stability test

  • extensive medical and toxicological literature review

  • blood levels of active constituents

 
 

pre-IND Development and FDA Submission

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  • develop pre-IND briefing document package

  • request FDA pre-IND meeting

  • submit pre-IND package

  • attend FDA pre-IND meeting

  • address any gaps

  • obtain botanical drug IND#

 

Botanical Drug Phase I Development

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  • develop phase-I clinical study protocol

  • identify, select, and manage a clinical trial company to implement the Phase I study protocol

  • analyzing data and complete phase-I FDA report

  • 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

  • identify, select, and manage a clinical trial company to implement the study protocol

  • conduct data analysis, develop study report, and submit to FDA

  • ​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

  • conduct road shows for drug products

  • ​coordinate and negotiate licensing terms

 

Botanical Drug Phase III Development

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  • develop clinical study protocol and submit to FDA

  • identify, select, and manage a clinical trial company to implement the study protocol

  • conduct data analysis, develop study report, and submit to FDA

  • ​discuss and interact with FDA till a final decision is made

 

GMP Service

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  • GMP facility design and FDA regulatory filing

  • GLP laboratory design and FDA regulatory filing

  • service all levels of US FDA GMP

  • Select and manage construction companines to execute GMP / GLP specifications

  • full service till receiving FDA permits

 

Strategic Alliance Service

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  • Connecting entities cross the global for botanical drug development

  • Connecting in-licensing and out-licensing entities

  • Identifying plant products for clients' specific needs of disease areas

  • Connecting manufactures and investors for botanical drug development

Philadelphia, USA