Gap Analysis

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

FDA regulatory consultation review client's current botanical drug development plans identify gaps in the US FDA botanical drug IND …

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