Who we are

Inka Petzelt is a degree engineer of Chemical Technology with main focus on biotechnology (academic studies in Darmstadt; Germany).

since 2005:
Founder and director of pci Petzelt-consulting-international GmbH

Focuses on consultation:

• Consultation on questions in the field of regulatory affairs relating to medical devices, in vitro diagnostics, drugs and food supplements.
• Notification and registration of medical devices, in vitro diagnostics, drugs and food supplements.
• Installation of quality management systems in small and medium sized companies.
• Coaching of small and medium sized companies in the field of process enhancement and optimization of products.
• Coaching of the company management concerning improvement in efficiency and effectivity of the company.
• Project director of research and development projects from the immunological field.

2000 - 2005:
Technical customer service manager Europe for an American market leader in the field of primary packaging for liquid drugs,
Controllership of the permission and market launch of primary packaging materials for the Chinese market
And permission at the SFDA (State Food and Drug Administration),
Project director at European studies within the framework of quality assurance.

1996 - 2000:
Assistant of the quality management director in a biotechnological company, project leader at European level for microbiological detection systems.

• Collaboration in assembling the quality management systems DIN EN ISO 9001, DIN EN ISO 13485
• Apprenticeship as internal auditor, further education in the section of GMP and TQM

Part-time academic studies as MBA – master of business (Switzerland)