Meet Our Experts

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Experts for: GMP

Heiner Zindel

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)
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
Anke Maaßen

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