Knowledge, Strategy, Success
Regulatory consulting from former FDA leaders, helping innovators accelerate development and approval of diagnostics, medical devices, and precision medicine solutions. Leveraging our extensive scientific expertise and real-world experience, we provide strategic guidance through the complexities of R&D, manufacturing, clinical trials, and regulatory compliance.
Our mission is to empower innovation, mitigate risks, optimize resources, and deliver tailored solutions that address unmet medical needs.
Regulatory Authority
Former FDA officials guiding U.S., EU, and global submissions.
Advanced expertise across molecular diagnostics, CDx, and clinical lab operations.
Scientific Depth
Global Access
Regulatory strategy for FDA, IVDR, and international markets.
Our Team
A Team Built on Regulatory Excellence
At YDX, you work directly with seasoned regulatory leaders who have evaluated, advised on, and guided the development of diagnostics, medical devices, digital health products, and companion diagnostics across industry and FDA.
Our team brings together decades of regulatory, scientific, and clinical experience. We combine rigorous analysis with practical judgment to help innovators succeed in today’s evolving regulatory environment.
Our Services
Regulatory Strategy Development
We assess the optimal regulatory pathway, identify key evidence needs, and develop actionable roadmaps for 510(k), de novo, PMA, and IVDR submissions.
FDA Engagement & Submission Support
From Q-Sub preparation to submission planning and interactive review, we guide teams through productive, focused communication with FDA and other health authorities.
Companion Diagnostics (CDx) Expertise
We help sponsors align biomarker strategy, analytical/clinical validation, and co-development expectations for U.S. and global markets.
AI/ML & Digital Health Guidance
We interpret emerging FDA policies, support risk-informed model development, advise on transparency and change-management frameworks, and help teams prepare for evolving expectations.