American Botanical Drug Corporation
www.BotanicalDrug.com
Expertise
*Extensive experience in preclinical studies for botanical APIs, including both small and large molecules or plant mixtures, drug substances, and drug products * utilizing chemical and biological techniques * Expertise in scaling up manufacturing processes for botanical APIs, drug substances, and drug product in a GMP environment to meet regulatory CMC requirement * Procurement of botanical raw materials * Specialized in U.S. FDA regulatory services and clinical development for botanical drugs
Botanical Analytics
Process development for isolating small and large molecules from plants
Development of HPLC methods tailored for botanical APIs and products
Analytic testing to ensure botanical API and product quality and compliance.
Certificates of analysis for botanical drug substances and products
Stability studies in ...
FDA INDs
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
Contact Us
Send Us A Message
Get in touch to discuss with us how we can best assist you.
Office location