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
In Vitro Diagnostics
IVD
Life-cycle Management
Program & Project Evaluation
Qualified Person
Quality Control and Assurance
R&D Strategies
Radiopharmaceuticals
Regulatory CMC
Risk Management
Scientific Writing

                    Non-clinical Research and Development
                  
        Contract Research Service
Disease Models
Drug Discovery
Due Diligence
Grant Application
Imaging Agents & Methodology
Interim Management
Oncology
Pharmacodynamics
Pharmacokinetics
Pharmacology
Preclinical Development
R&D Strategies
REACH
Scientific Marketing
Scientific Writing
Target Identification
Test Laboratory Service
Toxicology

                    Clinical Development
                  
        Biomarkers
Biostatistics
Business Development
Clinical Development Phase I
Clinical Development Phase II-III
Clinical Operations
Clinical Study Management
Drug Safety
Due Diligence
In Vitro Diagnostics
IVD
Health Economics and Market Access
Imaging
Licensing
Interim Management
Knowledge Management
Life-cycle Management
Medical Affairs
Medical Devices
Pharmacogenetics
PK-PD
Quality Risk Management
R&D Strategies
Submission Support
Translational Medicine
Vendor management
Vendor selection

                    Regulatory Affairs and Compliance
                  
        Conformity Assessment
CTAs
Drug Safety
Due Diligence
In Vitro Diagnostics
IVD
GxPs
Life-cycle Management
Medical Devices
Pharmacovigilance
Quality Assurance
Quality Systems
Regulatory Affairs
Regulatory Strategies
Scientific Advice Procedures
SOPs
Submissions

                    Business Strategy & Development, Intellectual Property and Corporate Design
                  
        Agreements & Contracts
Business Development
Business Representation
Commercial Strategy
Commercial Operations
Communication
Corporate Design
Corporate Finance
Funding Opportunities
General Management
Intellectual Property
Interim Management
Law
Licensing
M&As
Market Research
Marketing
Sales
Social Media
Trademarks

Experts for: Submissions

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