A well-designed preclinical programme is not only the basis for a successful clinical phase of drug candidates, but generates cost efficiencies during further development of the product. Based on our extensive experience in accompanying substance and drug candidates during their preclinical development, we can offer the following services to our clients:

Preclinical Development
• Development of a preclinical strategy for your drug candidate
• Preparation of meetings with regulatory authorities
• Toxicological studies & animal models, pre-clinical kinetics
• Peer reviews

Risk Assessments
• Generation of Benefit-Risk Assessments
• Extracables & Leachables (E/L)

CRO Management
• Selection of competent preclinical CROs for your drug candidate
• Auditing, monitoring
• Management of all Sponsor-CRO activities

Pharmacovigilance
• National Safety Officer (§63 AMG)
• (Interim) EU-QPPV
• Audits of Pharmacovigilance Systems