Team

Dr. Gerd Paulus, Managing Partner

Senior GxP Consultant
General Management in GxP-Environments
Project/Change Management in GxP-Environments
Risk Assessment and Data Integrity Expert
Implementation of ICH guidelines

Dr. Martin Seiler, Partner

Senior GxP Consultant and Auditor
Practice-oriented quality assuring systems (GxP and ISO)
Fast structural analysis
Interface optimisation
Implementation of long-term business relationships
R&D and production

Christoph Jeggle, Senior IT Consultant

CSV expert
Information technology
Organisation Project management
Change management
Quality management
Software validation
Programming

Gabriela Gubler, GxP-Consultant

Expert Bioanalytical QC
Data integrity expert
Data control for preclinical and clinical studies
Revision of study plans and reports

Judith Scheuschner

Administrative support in GxP-Environments

Dr. Eberhard Bock, Senior RA Consultant

Change Control Expert
Drug Regulatory Affairs Consultant
Focus to International Quality Assurance
Main focus on Corporate Change Control and Quality Agreements

Pia Stobbe

Administrative support in GxP-Environments

Florian Fricke, GxP Consultant

Study Director
Senior CSV Specialist

Manuel Birke, Senior GxP Consultant

Expert large molecules