CRO Service
info @ BotanicalDrug . com
Gap Analysis
FDA Botanical Drug Guidance consultation
review client's current botanical drug development status
list gaps for the US FDA botanical drug IND application
define strategies to close gaps
provide time and cost estimate
Botanical Drug pre-Clinical
qualitative analytics of botanical drug 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 drug products
develop drug product quality control methods and standards
animal safety test
stability test
extensive medical and toxicological literature review
blood levels of active constituents
pre-IND Development and FDA Submission
develop pre-IND briefing document package
request FDA pre-IND meeting
submit pre-IND package
attend FDA pre-IND meeting
address any gaps
Botanical Drug Clinical Development
develop FDA IND application package with clinical study protocols
identify, select, and manage a clinical trial company to implement study protocols
analyzing data and complete FDA report
maintain dialogues with US FDA
Out-licensing of Phase I and II approved products
represent sponsors to engage big pharma companies
conduct road shows for drug products
coordinate and negotiate licensing terms
GMP Manufacturing Center
GMP certified for botanical products, located outside NYC
Scale up from R&D to cGMP manufacturing
Technology transfer
Drug development process
Formulation optimization
Clinical trial materials GMP manufacturing
Pharmaceutical products manufacturing
Release testing
Certificates of Analysis
Stability studies according to ICH guidelines
Commercial product manufacturing