Expert in Biotechnology and Regulatory Affairs
Professional Profile
Welcome to the professional profile of Donat De Groote, a recognized expert in biotechnology, diagnostics, and medical devices, with over 40 years of experience in scientific research, business management, and regulatory compliance.
Combining a strong scientific background with executive leadership, Donat has established himself as a trusted regulatory affairs leader and strategic advisor for companies in the healthcare and life sciences industries.
As the founder and managing director of AZ Biotech Consulting since 2011, Donat provides executive and freelance consulting services to both established companies and start-ups. His expertise spans regulatory affairs, medical affairs, and business development support for emerging organizations.
He has participated in numerous steering committees and research projects, particularly in the field of in vitro diagnostics (IVD).
Regulatory Affairs Expertise
Regulatory affairs have been the cornerstone of Donat’s professional career.
He has held several key leadership roles, including QA/RA Manager and PRRC (Person Responsible for Regulatory Compliance), where he was responsible for the implementation and certification of Quality Management Systems (QMS) in accordance with ISO 13485.
His expertise includes:
- Achieving CE marking for medical devices (hardware, software, and IVDs);
- Authoring and validating technical documentation;
- Supporting the development and regulatory approval of innovative medical and diagnostic products in fields such as cardiology, clinical nutrition, and molecular diagnostics.
Throughout his career, Donat has helped organizations accelerate market access by ensuring the quality, safety, and regulatory compliance of their products under European and international frameworks.
Education and Academic Background
Donat holds:
- A PhD in Sciences, specialized in Immunology,
- A Master’s Degree in Biology from the Université Libre de Bruxelles (ULB),
- And a Postgraduate Diploma in Management from the Solvay Business School, focused on business creation and administration.
This unique combination of scientific, regulatory, and managerial expertise makes Donat a strategic partner for any organization involved in biotechnology, diagnostics, or medical device development.