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: Biopharmaceuticals
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
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
Heiner Zindel
Expert for Biotech Process Development and Manufacturing
- Business Development and Support for CMO/CRO’s
- Process Development (USP and emphasis on DSP)
- Qualifications / Validations (DQ, IQ, OQ, PQ based on an FMEA approach)