Regulatory, Medical and Medico-marketing Consulting

  • Phase I to IV development plans
  • Consulting and streamlining of clinical projects
  • Protocol development and study reports
  • Expert statements of board certified Clinical Pharmacologists and other experts
  • Briefing books and Expert Reports
  • Responses to authorities
  • Staff Trainings, SOP development, structural analyses
  • Audits

Scientific Writing and Communication

  • Strategic communication plans
  • Medical writing (reviews, original papers, abstracts)
  • Study protocols and reports
  • Investigator brochures
  • Expert reports, expert statements and monographs
  • Clinical and Nonclinical Overviews
  • Periodic Safety Update Reports
  • Clinical and preclinical CTD documents
  • SAE reportingand writing of narratives
  • Germany: Expert statements §24 German Drug Law, Experience Reports
  • Germany: Nutzenbewertung (G-BA), input to dossiers
  • Scientific information retrieval
  • Medical education materials
  • Posters for scientific congresses
  • Presentations, slide kits
  • Books (including full project management)

Pharmaco-epidemiological and Public Health research projects