Meet Our Experts
Please select a topic:
Chemistry, Manufacturing and Control
Non-clinical Research and Development
Clinical Development
Regulatory Affairs and Compliance
Business Strategy & Development, Intellectual Property and Corporate Design
Experts for: Regulatory CMC
Michael Hildebrand
Expert for CMC, Biopharmaceuticals and QP topics
- CMC support from research to life cycle management
- Formulation development and Quality Control
- GMP and Qualified Person support
Anke Maaßen
Expert 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 Dürr
Expert 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