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
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Funding Opportunities
General Management
Intellectual Property
Interim Management
Law
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Market Research
Marketing
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Social Media
Trademarks

Experts for: Medical Devices

Anke MaaßenExpert for In Vitro Diagnostics (IVDs)
Regulatory Affairs (EU regulations: IVDD and IVDR)
Quality Management and Assurance
Internal and Supplier Audits
Support for Manufacturing and Control
Siglinde DürrExpert for Quality Assurance
Implementation of Quality Systems according to GMP, GCP or ISO regulations
Conduct quality audits (GMP/GCP/ISO)
Develop and implement Standard Operating Procedures
Project management of funded projects

                          Michael Zimmermann
                          Expert for conformity assessment according to Regulation (EU) 2017/745 (MDR)
Clinical investigations and clinical evaluations
PMCF
Technical documentation and Design Dossiers
Seminars and training courses on clinical investigations and clinical evaluations

                        