Clinical Development

WE DEVELOP TAILOR-MADE SOLUTIONS FOR YOUR DEVELOPMENT PROJECTS THROUGHOUT THE CLINICAL STAGES OF ITS LIFE CYCLE.

Clinical Development

The clinical development team is an international group of experienced professionals trained in clinical medicine and research, biology, and pharmaceutical sciences. Their extensive scientific and hands-on experience in industry and academia will bring your clinical development projects to success and offer practical 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
  • Pediatric investigational plans
  • Orphan drug designations
  • Clinical trial planning, management, and evaluation and interpretation of results
  • Compilation, maintenance, and storage of clinical trial masterfiles
  • Investigator´s brochures
  • Investigational medicinal product dossiers
  • Systematic literature searches
  • Scientific justification for reclassification of products (Rx- and OTC-Switch)
  • Biowaiver justification
  • PSURs
  • DSURs
  • Feasibility assessments and gap analysis for project assessments
  • Due diligence for in-Licensing candidates
  • Identification of qualified service partners, key opinion leaders and scientific experts
  • Clinical evaluation of medical devices
  • Medical Writing

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