Meet Our Experts

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Experts for: Regulatory CMC

Michael Hildebrand

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

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
Mónica Unger-Bady

Mónica Unger-Bady

Expert for Regulatory Compliance in Pharmaceutical Industry

  • Analysis, individual consultation, implementation
  • Project management, interim management
  • Business analysis
  • Coaching and Training