Preclinical Development

Our preclinical experts have a long-standing experience in preclinical research, toxicology, and regulatory.

Therefore, we can help you with:

  • Preclinical development planning
  • Preclinical study planning and management, evaluation and interpretation of results
  • Compilation of the preclinical parts of the CTD
  • Compilation of Investigator´s Brochures and IMPDs
  • Handling of Assessment Reports as well as answering of questions and handling of recommendations of authorities
  • Compilation of Briefing Documentation for Scientific Advice procedures and discussion of preclinical questions with the authorities
  • Systematic literature searches
  • 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
  • Biocompatibility Assessment for Medical Devices
  • Safety Assessments for impurities and excipients

Clients & Testimonials