Navigating Toxicology and Non-Clinical Drug Development — Together.

Non-clinical and Toxicology Consultant based in Vienna, Austria
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Expert Non-Clinical & Toxicology Consultant

I am a committed consultant with extensive experience supporting national and international clients—including biotech companies, start-ups, and SMEs. With a strong focus on innovative non-clinical drug development, I approach each project with dedication and a deep sense of responsibility, helping you to navigate complex challenges and to move forward with confidence.
About Me

10+

years non-clinical consulting

30+

IND/CTA enabling non-clinical packages

50+

toxicological risk assessments

Your Questions – My Expertise

01

How can we define the human starting dose?

02

Which non-clinical program do we need to reach the first-in-human clinical trial?

03

Which regulatory agency should I contact and when would be the ideal timepoint for a scientific advice meeting?

04

Which species should we select for the GLP toxicity studies?

05

How much time and costs do I need to calculate for the non-clinical development?

06

We have a finding in a GLP toxicity study: what do we do now?

07

Which CRO should we select for our GLP toxicity studies?

08

How do we present the non-clinical data in regulatory documents?

Core services

Tailored non-clinical plans

A product-specific non-clinical plan from candidate selection through clinical readiness and until marketing authorization.
  • Gap analyses
  • Non-clinical plans
  • Estimations of timelines and costs for proposed non-clinical programs

Support for non-GLP and GLP studies

Strategically designed protocols, expert CRO selection, proactive study monitoring, and insightful data interpretation
  • Study designs
  • Request for proposals
  • CRO selection
  • Study monitoring
  • Support for study audits
  • Review of study plans and reports

Regulatory assistance

Regulatory support from agency selection through submission and expert management of feedback responses.
  • Scientific advice meetings (FDA, national European Agencies, EMA)
  • Ad hoc support for preparation of response to Agency's feedback on IND / CTD / CTA
  • Classification of ATMPs

Scientific writing expertise

Expert scientific writing for clear, accurate, and agency-ready documentation.
  • Briefing Documents
  • INDs
  • CTDs
  • IBs / IMPDs
  • Study reports
  • Publications

Toxicological risk assessments

Expert toxicological assessments to ensure safety and regulatory compliance
  • Excipients
  • Impurities
  • PDEs / OELs
  • Expert statements (e.g. reproductive and developmental toxicity, juvenile toxicity)
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