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Assisting pharmaceutical companies and other organizations in evaluating, developing, implementing and managing:

  • Healthcare professional information
  • Patient information
  • Labeling policy, processes, organizations and technology

Providing expertise in:

  • US and EU labeling
  • Creating and implementing core labeling (incl. CCSI and supporting justifications for safety labeling changes)
  • Designing effective and defensible safety labeling
  • Target labeling, labeling development during drug development
  • Managing complex labeling and regulatory situations - whether local or global
  • Designing efficient and defensible labeling policy and processes

Supporting regulatory/labeling, pharmacovigilance, medical, clinical, marketing and law departments.

Pharmiceutics LLC is a Pennsylvania company, founded in 2005.

Principal consultant: Dr. med. A. Leander Fontaine

Our clients include many large, mid-size and smaller pharmaceutical companies - in North America, Europe, Japan, and other regions.

Pharmiceutics' offices are located in Downingtown, Pennsylvania, approximately 25 miles west of Philadelphia. Our regular office hours are 9 am - 5 pm (9:00-17:00) EST ("Philadelphia - New York time").