About AZ Biotech Consulting

Welcome to AZ Biotech Consulting, a leading advisory firm recognized for its expertise in biotechnology, diagnostics, and medical devices.
With over 13 years of experience, we support our clients at every stage of their projects through specialized regulatory affairs, strategic consulting, and business development services.

Our Expertise

AZ Biotech Consulting provides a comprehensive range of services tailored to the specific needs of the biomedical and medical device sectors.
With strong expertise in regulatory and medical affairs, we assist in the creation, structuring, and growth of innovative start-ups, while also collaborating successfully with established companies.
Our support includes strategic analysis, participation in steering committees, and guidance for research and development projects, particularly in the field of medical devices.

Excellence in Regulatory Affairs

Regulatory affairs are at the core of AZ Biotech Consulting’s services.
Our proven experience covers the implementation and management of quality management systems (QMS), achieving ISO 13485 certification, and obtaining CE marking for medical devices, medical software, and in vitro diagnostic devices (IVDs).
We help our clients meet and exceed regulatory requirements while facilitating the development and market access of innovative solutions — particularly in the area of medical software.