Meet Our Experts

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                    Chemistry, Manufacturing and Control
                  
        Audit
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Due Diligence
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        Contract Research Service
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Experts for: Due Diligence

Sabine PilariExpert for Pharmacometrics and PK/PD Modeling
PK and PK/PD analyses, including exposure-response, mechanistic, and PBPK modeling
Human PK prediction and estimation of efficacious & starting doses
Pharmacometrics analysis, population PK, and PK/PD modeling
Guidance on dose selection and dosing regimen optimization for clinical studies
Katja WosikowskiExpert 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
 
Frank S. ZollmannExpert for Pre-/ Clinical Drug Development
Safety pharmacology, toxicology, pharmacogenomics
Integrated preclinical & clinical development up to PoC
Clinical pharmacology
Michael HildebrandExpert for CMC, Biopharmaceuticals and QP topics
CMC support from research to life cycle management
Formulation development and Quality Control
GMP and Qualified Person support