SERVICES
Services provided by Thomas Q. Garvey III, MD
- Design of clinical trials and programs of trials for
- Pharmaceuticals
- New drugs
- Generic drugs
- Over-the-Counter (OTC) drugs
- Medical devices
- Biologics
- Labeling for new drugs and modifications of labeling for marketed drugs
- Analysis of clinical trial data
- Safety analysis for drugs in development and marketed drugs
- Program development for switching prescription drugs to OTC status
- Composition of clinical sections of New Drug Applications (NDAs)
- Composition of Investigational New Drug Exemption (IND) submissions
- Problem-solving for new drugs and drugs in development
- Preparation for meetings with the Food and Drug Administration (FDA), FDA advisory committees, and foreign regulatory agencies
- Expert testimony on
- Drug labeling
- Failure-to-warn
- FDA's drug approval process
- Lanham Act actions
- Regulatory issues
Services provided by Carol W. Garvey MD, MPH
- Community health assessment and planning
- Analyzing measures of community health
- Addressing health disparities/health inequity
- Improving pregnancy outcomes
- Implementing obesity prevention and reduction measures
- Expanding access for underserved populations
- Identification of community health resources
- Liaison to healthcare organizations