Expert consultation in Health, Academia, and Education
The LUNA Health Consultancy
Expert advice where needed
I am proud to have started the LUNA health consultancy FZCO: an specialist advisory service offering nice expertise in the field of applied clinical research, regulatory medical device approvals, academia, and medical education.
With other 11 years expertise in this domain, I offer advanced expertise to commercial partners with specific research needs.
With LUNA Health Consultancy, we guarantee faster access to success through innovative and break through research design
Accelerating Market Approval for a Novel Medical Device
Challenge: A medtech startup needed to secure EU MDR compliance for its AI-driven diagnostic device but lacked regulatory expertise.
Solution: Our team conducted a gap analysis, developed a robust technical file, and guided them through clinical evaluation requirements.
Outcome: Successful CE marking within 12 months, enabling market entry ahead of competitors.
Optimizing Clinical Trial Design for a Rare Disease Therapy
Challenge: A biopharma company faced delays in FDA discussions due to insufficient evidence for a rare disease drug.
Solution: We redesigned the trial protocol with patient-centric endpoints and aligned stakeholder communications.
Outcome: Faster regulatory alignment, leading to Phase III approval and accelerated patient access.
Transforming Medical Education for a Global Pharma Leader
Challenge: A pharmaceutical client needed an innovative, compliant education strategy to support HCPs in a new therapeutic area.
Solution: We developed an accredited digital learning platform with real-world case integration and outcomes tracking.
Outcome: Improved HCP engagement, with 85% of participants reporting enhanced clinical confidence.
Collaboration
If you want to travel fast, you should travel alone, but if you want to travel far, you should certainly travel with like-minded friends. I enjoyed setting up several international collaborations towards common causes in women’s health (link), as well as harnessing local support towards a common cause (link). I welcome opportunities to collaborate with like-minded individuals who put the benefit of the collective above the benefit of the one (Link).