We believe every day saved in the regulatory process is a day a treatment reaches a patient sooner.
SyneticX was founded on a single conviction: that the pace of healthcare innovation should never be limited by the tools available to the people driving it. We are a life sciences technology company building the infrastructure that regulatory, clinical, and scientific teams need to operate at the frontier — combining deep domain expertise with AI built specifically for the complexity of drug and device development.
Our flagship platform, Leaf AI, exists to remove the friction between discovery and approval — giving regulatory teams the intelligence they need to move with confidence. Because we believe the most meaningful advances in medicine shouldn't take longer to approve than they took to invent.
The regulatory process is one of the most consequential bottlenecks in healthcare. A promising therapy can spend years navigating approval pathways, not because the science isn't ready, but because the information needed to make critical decisions is scattered across thousands of documents, databases, and jurisdictions.
Every day a treatment is delayed by inefficient regulatory processes is a day it doesn't reach the patients who need it most.
We made Leaf AI because we saw this problem first-hand. Regulatory professionals — some of the most important people in the drug development process — were spending their days manually searching FDA databases, cross-referencing guidance documents, and assembling reports from dozens of disconnected sources. The tools they had were built for a different era.
We're changing that. By combining advanced AI with the deepest regulatory data infrastructure ever assembled, Leaf AI gives teams instant access to the intelligence that used to take weeks to compile. Every answer is source-cited, every claim is traceable, and every output is built to the standard that regulators expect.
But technology alone isn't enough. That's why SyneticX works alongside former FDA counsel, regulatory lawyers, and subject-matter experts who understand what's at stake. Leaf AI isn't just fast — it's built with the rigour and accuracy that life sciences demands.
Across our lifetime, we intend to contribute to a measurable acceleration in how treatments reach the people who need them. Not incrementally — but fundamentally. We envision a world where AI collapses the distance between a scientific breakthrough and its approval, where regulatory complexity is no longer a barrier to innovation, and where the next generation of life-changing therapies reaches patients years sooner than they would have otherwise. That is the work SyneticX is here to do.
We measure our success not in queries answered, but in the time we give back to the teams working to bring life-changing therapies to market. Faster intelligence. Faster decisions. Faster to patients.
The principles that guide everything we build.
Every answer cites its source. Every claim is traceable. We never ask you to trust a black box — we show our work.
Behind every regulatory decision is a patient waiting. We build with urgency because the stakes are real and the timelines matter.
Fast doesn't mean careless. We deliver in seconds what used to take weeks — without compromising the accuracy regulators demand.
AI amplifies expertise — it doesn't replace it. Our platform is built and validated with former FDA professionals who know what good looks like.
Regulation evolves constantly. Our data, models, and insights update in real-time so you're always working with the latest intelligence.
Your data is your competitive advantage. Enterprise-grade security, SOC 2 compliance, and zero data sharing — no exceptions.
Former FDA counsel, AI engineers, and data scientists — united by the mission to modernise regulatory intelligence.
Mark is a seasoned FDA regulatory attorney and former counsel at the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER). With more than two decades of experience spanning government, industry, and private practice, he has advised global pharmaceutical companies, trade associations, and emerging innovators on complex regulatory, compliance, and international market issues. Based in Kentucky, Mark is the founder of White Oak AI Law, where he focuses on the intersection of life sciences and artificial intelligence. As both an advisor and investor in our company, he brings unparalleled insight into FDA regulatory pathways, compliance strategy, and the evolving landscape of biopharma innovation.
Rohan has a background in computer science and economics, with a focus on building AI systems that improve efficiency across life sciences while maintaining accuracy and precision. Passionate about shortening development timelines through automated research so treatments reach patients faster.
Alexander brings a strong foundation in mathematics and computer science to solving some of the most complex challenges in life sciences and technology. Passionate about applying AI to uncover insights from difficult-to-access data and has built tools that help leaders make sharper, faster decisions.