Articles & Presentations
We hope some of the following articles and presentations provide you with useful information on different aspects of clinical product development. Please note that these files are in PDF format. If needed, download a PDF reader from the link at the bottom of the page.
ARTICLES
Developing Traditional Chinese Medicines as Botanical Drugs for the US Market
Developing Botanical Products from India for the US Market
Practical Aspects of Conducting Clinical Trials in India
Forecasting for Success: The Power of Regulatory Gap Analysis
Regulatory Harmonization Efforts in India: Keeping in Step With the Globe
Designing a Global Product Development Strategy
Regulatory Considerations for Conducting Clinical Trials In India
The Promise of Biogenerics: Hope and Hype
RECENT PUBLIC PRESENTATIONS
Please contact Patrick Burke at patrickb@amarexcro.com for handouts of these presentations.
- Opportunities in Developing Orphan Drug Products
- Regulatory Issues with Natural Products
- Adaptive Clinical Trials: Regulatory & Statistical Perspectives
- Preparing for an FDA Audit for GCP Compliance
- Changing Regulatory Environment in India for Clinical Trials, etc.
- Meeting the FDA
- Managing International Clinical Trials
- Building Productive Pipelines by Technology Transfer
- Do's and Don'ts of Outsourcing
- Electronic Submissions to the FDA
- FDA Acceptance of Foreign Clinical Trial Data
- Applicable Clinical Trials for Clinical Trial Registration
