American Botanical Drug Corporation
Developing Safe And Efficacious Plant Products To Botanical Drugs Is An Efficient Drug Development Pathway
About American Botanical Drug Corporation
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Here at American Botanical Drug Corporation, we are a contract research organization (CRO) specialized in developing botanical products (herbal and hemp) to prescription botanical drugs through US FDA botanical drug IND regulatory filing and clinical development, and contract manufacturing organization (CMO) for ...
FDA Botanical Drug Guidance
In 2004, the FDA issued Botanical Drug Development Guidance for Industry; In 2016, 2nd edition. If a drug product is derived from a single plant or from a mix of plants, the Guidance waives the requirement of:
Identifying active ingredients; Description of the mechanism of action.
As long as a botanical product ...Information
Botanical Drug
Botanical Drug
FDA Approves Crofelemer as First-Ever Oral …
On New Year's Eve of 2012, the US Food and Drug …
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Bio-pharmaceutical Consulting | CRO Service
Bio-pharmaceutical Consulting | CRO Service
Gap Analysis
Our gap analysis service will help you with FDA Botanical Drug Guidance consultation, review your current botanical drug development …
Read MoreBotanical Drug pre-Clinical
On this service, we do the qualitative analytics of botanical drug products with complext ingredient profiles and quantitative analytics …
Read MorePre-IND Development & FDA Submission
We can help you through the process, with our help we can develop a pre-IND briefing document package, request FDA pre-IND meeting, Submit …
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