American Botanical Drug Corporation

CRO Service

Gap Analysis

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• 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

Botanical Drug pre-Clinical

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• 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

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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

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

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Botanical Drug Clinical Development

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• 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

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