Specific services available for your organization include:
Clinical Development, Regulatory Communications, Technical Writing
- Interpret FDA policies and guidelines
- Develop U.S. labeling (e.g., physican and patient package inserts, cartons and vials)
- Direct FDA Advisory Committee preparations, briefing documents and presentations
- Provide regulatory input to the marketing promotional materials review process
- Technical writing, compilation and/or detailed critical reviews of all aspects of regulatory submissions and communications
- Present or prepare presentations for investors and Boards involving development of drugs, biologics, or combination products