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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