Regulatory Service for Botanical IND

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

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

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
Pharmacology studies to determine mechanism of action and therapeutic effects
Acute, repeat-dose, genotoxicity, and carcinogenicity toxicology studies
Safety Pharmacology related to vital organ systems, such as the cardiovascular, central nervous, and respiratory systems
Pharmacokinetics (PK) Studies to understand absorption, distribution, metabolism, excretion.

Quality Control & CMC Development

develop quality control method for full-spectrum botanical drug substances and products
manufacturing process
drug product formulation
stability testing

IND Development and FDA Submission

develop IND document package
request and attend FDA IND meetings
submit IND packages
address FDA questions

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 supporting clients' preIND, phase 1, phase 2, and phase 3 INDs.

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