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FDA regulatory filings for drug products include those containing small and large molecules derived from plants, as well as full-spectrum botanical extracts.
Book an initial free consultation
GAP Analysis
GAP Analysis
FDA regulatory consultation
review client's current botanical drug development plans
identify gaps in the US FDA botanical drug IND application
develop strategies to close gaps
provide time and cost estimate
Botanical Drug pre-Clinical
Botanical Drug pre-Clinical
analyze botanical 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 products
establish quality control methods for botanical drug products
animal safety tests
stability tests
IND Development and FDA Submission
IND Development and FDA Submission
develop IND document package
request and attend FDA IND meetings
submit IND packages
address FDA questions
Quality Control & CMC Development
Quality Control & CMC Development
develop quality control method & standards for full-spectrum botanical APIs and products
develop the full CMC
Clinical Development
Clinical Development
develop FDA IND application package with clinical study protocols
identify, select, and oversee a clinical trial company to implement the study protocols
analyze data and complete FDA reports
engage with the US FDA to address queries and provide updates.
Case Study Training
Walking through some of FDA approved botanical drug IND/NDA cases:
Veregen
Fulyzaq
other cases
We have extensive experience in preIND, phase 1, phase 2, and phase 3 INDs.
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