Meet Our Experts

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Experts for: CTAs

Katja Wosikowski

Expert for Nonclinical Drug Development

Preclinical pharmacology, safety pharmacology, immunology, toxicology, pharmacokinetics and BA method development
Translation to early clinical studies including of PK, ADA and Biomarker analysis
Documents for CTA and IND

Michael Firgens

Expert for Regulatory Affairs and Global Development Strategy

Interactions with regulatory authorities in EU and US
Requests for regulatory expedited programs
Clinical trial documents
Support for marketing authorization applications