Dr. Jess Amchin, individually or with his team of associates, provides consultation in a variety of areas, including:
MEDICAL AFFAIRS (supporting product development and commercialization)
- Research (post-market studies):
- Protocol development, execution of studies, review of results
- Preparation of clinical study reports, publications, presentations
- Medical review of promotional material
- Development of educational or promotional material
- Publication development
- Professional Services/Medical Information, standard response letters
- Scientific Advisory Boards
- Development of educational material
CLINICAL RESEARCH AND DEVELOPMENT
- Research (pre-market studies):
- Protocol development, execution of studies, review of results
- Preparation of clinical study reports, publications, and presentations
- Product labeling
- Support for FDA submissions and presentations including:
- NDA study reports and summaries
- FDA meeting preparation
CORPORATE BUSINESS DEVELOPMENT & EXECUTIVE LEADERSHIP
- Business plans
- Strategic development
- Corporate Advisory Boards
- Business opportunity assessments
- Venture capital fund-raising
- Corporate or department organization development
- Professional staff training and development
- Board of Directors
PHARMACEUTICAL-RELATED LEGAL MATTERS