Meet Our Experts

Please select a topic:

                     
                    Chemistry, Manufacturing and Control
                  
        Audit
Biopharmaceuticals
Cell Lines
CMO & CRO Selection and Management
Due Diligence
Formulation Development
GMP
Interim Management
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IVD
Life-cycle Management
Program & Project Evaluation
Qualified Person
Quality Control and Assurance
R&D Strategies
Radiopharmaceuticals
Regulatory CMC
Risk Management
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                    Non-clinical Research and Development
                  
        Contract Research Service
Disease Models
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Due Diligence
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Interim Management
Oncology
Pharmacodynamics
Pharmacokinetics
Pharmacology
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REACH
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                    Clinical Development
                  
        Biomarkers
Biostatistics
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Clinical Development Phase I
Clinical Development Phase II-III
Clinical Operations
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Due Diligence
In Vitro Diagnostics
IVD
Health Economics and Market Access
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PK-PD
Quality Risk Management
R&D Strategies
Submission Support
Translational Medicine
Vendor management
Vendor selection

                    Regulatory Affairs and Compliance
                  
        Conformity Assessment
CTAs
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Life-cycle Management
Medical Devices
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Submissions

                    Business Strategy & Development, Intellectual Property and Corporate Design
                  
        Agreements & Contracts
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Trademarks

Experts for: Clinical Development Phase II-III

Astrid SchottExpert for Clinical Research & Development
Clinical Development planning, Phase I-III
Interim management
Due Diligence, licensing
Christian WolfExpert for Clinical Development & Life Cycle Management
CNS indications (MS, epilepsy, stroke)
Strategy, operations and interim management
Business development
Johannes LampeExpert for Clinical Research & Development
Clinical development, Phase I-IV (Neurology, Immunology)
Medical regulatory strategy
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

                          Christian Hucke
                          Clinical and non-clinical Project Management
Interim Management, Strategy
Clinical Operations, Clinical Study Management
Quality Risk Management

                        