American Botanical Drug Corporation
CRO Service
Gap Analysis
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FDA Botanical Drug Guidance consultation
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review client's current botanical drug development status
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list gaps for the US FDA botanical drug IND application
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define strategies to close gaps
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provide time and cost estimate
Botanical Drug pre-Clinical
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qualitative analytics of botanical drug products with complext ingredient profiles
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quantitative analytics of drug substances: 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
Existing customers, click here see the list of data requirement with detailed explanation
Botanical Drug Clinical Development
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develop FDA IND application package with clinical study protocols
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identify, select, and manage a clinical trial company to implement study protocols
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analyzing data and complete FDA report
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maintain dialogues with US FDA
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
