Clinical Development

Our Medical Team is an international group of experienced professionals, trained in clinical medicine, biology and pharmaceutical sciences, which have extensive scientific and hands-on experience in clinical medicine, clinical research and regulatory, both in industry and academia.

We offer support with:

  • Clinical development planning
  • Dossier preparation (CTD)
  • Consultation with regulatory authorities for scientific advice
  • Briefing Documentation for Scientific Advice procedures
  • Protocol assistance for orphan drugs
  • Product Information Texts
  • Risk Management Plans
  • Handling of Assessment Reports
  • Paediatric Investigational Plans
  • Orphan Drug Designation
  • Clinical Trial planning and management, evaluation and interpretation of results
  • Compilation, Maintenance and Storage of Clinical Trial Masterfiles
  • Investigator´s Brochure
  • Investigational Medicinal Product Dossier
  • Systematic literature searches
  • Scientific justification for reclassification of products (Rx-, OTC-Switch)
  • Biowaiver justification
  • Feasibility Assessment and Gap Analysis for project assessment
  • Due Diligence for In-Licensing candidates
  • Identification of qualified Service Partners, Key Opinion Leaders and Scientific Experts
  • Clinical evaluation of medical devices
  • Medical Writing

Clients & Testimonials