CRO Service

Gap Analysis

  • FDA Botanical Drug Guidance consultation

  • review client's current botanical drug development status

  • list gaps for the US FDA botanical drug IND application

  • define strategies to close gaps

  • provide time and cost estimate

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Botanical Drug pre-Clinical

  • qualitative analytics of botanical drug products with complext ingredient profiles

  • quantitative analytics of drug substances: 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

  • develop pre-IND briefing document package

  • request FDA pre-IND meeting

  • submit pre-IND package

  • attend FDA pre-IND meeting

  • address any gaps

Existing customers, click here see the list of data requirement with detailed explanation

 

Botanical Drug Clinical Development

  • develop FDA IND application package with clinical study protocols

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

  • analyzing data and complete FDA report

  • maintain dialogues with US FDA

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Out-licensing of Phase I and II approved products

  • represent sponsors to engage big pharma companies

  • conduct road shows for drug products

  • ​coordinate and negotiate licensing terms

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