Jess Amchin, M.D., J.D.
Pharmaceutical Consultant
Services

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