Pre-clinical Development

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

- Dr. Andrea Niese Head of Medical & Pre-clinical, Physician

Pre-Clinical Development

Our pre-clinical experts have long-standing experience in pre-clinical research, toxicology, and regulation, and can assist you in:

  • Pre-clinical development planning
  • Pre-clinical study planning, management, and evaluation and interpretation of results
  • Compilation of the pre-clinical parts of the CTD
  • Compilation of investigator's brochures and IMPDs
  • Handling of assessment reports and authorities recommendations
  • Collection of briefing documentation for scientific advice procedures and discussion of pre-clinical questions with authorities
  • Systematic literature searches
  • 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
  • Biocompatibility assessments for medical devices
  • Safety assessments for impurities and excipients

Have a question concerning pre-clinical development? Contact Dr. Andrea Niese.