Brilliant science deserves more than guesswork. RCI Global Partners brings elite regulatory, clinical, and commercialization strategy to the MedTech, Biotech, and Pharma founders building the future of healthcare – combining big-company expertise with startup-savvy speed. We don’t just keep you compliant. We align the decisions that determine your timeline, your clinical burden, and your valuation.
RCI Global Partners is a regulatory and clinical strategy firm serving emerging MedTech, Biotech, and Pharma companies in the U.S. and internationally. Our consultants have led clinical affairs, regulatory strategy, and market access inside organizations like Medtronic, Smith+Nephew, and Stryker – and have guided more than 200 medical innovations to market across the U.S., Canada, Europe, China, and Australia.
We founded RCI Global Partners on a conviction: the caliber of strategy available to a global device or pharma giant shouldn’t be out of reach for the companies actually doing the inventing. So we built a firm that delivers it – at a speed and cost that fits a startup’s runway, with the rigor that FDA and investors demand.
Startups face limited capital, high expectations, and zero room for error. Compliance checklists don’t protect you from the mistakes that actually kill companies. Architecture does.
We sequence your regulatory, clinical, and commercial decisions before you spend – so every dollar of evidence generation serves your submission, your label, and your next raise.
Our team has sat inside global manufacturers, hospital systems, and academic research – and across the table from FDA. We know how the agency thinks because we’ve prepared for, and sat in, those meetings for two decades.
510(k), De Novo, PMA, IDE on one side; pre-IND, IND, and clinical development sequencing on the other. Few firms hold genuine depth in both MedTech and Biotech/Pharma pathways. We’ve launched products in each.
Regulatory strategy isn’t just an FDA exercise – it’s the backbone of your valuation. We structure milestones and evidence so your progress is legible to the people funding it, supporting investor readiness, M&A diligence, and go-to-market.
Senior consultants only. Every RCI engagement is led by practitioners who have run these pathways themselves – no leverage model, no hand-offs to junior staff.
Clinical scientist and award-winning regulatory strategist with 20+ years leading global clinical affairs and market access at Medtronic, Smith+Nephew, and Stryker. She has extensive experience leading regulatory and clinical business units, managing complex product portfolios, and guiding teams through high‑stakes launches, M&A, and global expansion.
Crissey holds a PhD in Chemistry from Vanderbilt University, where she led complex research programs from experimental design through regulatory and safety compliance. She brings scientific rigor to RCI’s MedTech clients, translating deep technical expertise into the operational discipline that regulatory strategy demands.
Krishna brings a decade of quality engineering experience across Johnson & Johnson, Dexcom, and FTI Consulting, with deep expertise in QMS design, CAPA remediation, and audit-ready compliance frameworks. She helps RCI clients treat quality as the operational backbone of patient safety and market readiness, not a regulatory checkbox.
Lidya earned her PhD in Pharmaceutical Sciences from the University of Tennessee, where her research uncovered novel therapeutic targets for liver disease. She applies that bench-to-market perspective at RCI, helping Pharma and MedTech founders turn rigorous science into regulatory strategy that actually reaches patients.
Natalie is a practicing Certified Physician’s Assistant in hospital internal medicine at Mayo Clinic Florida, with a specialized focus on integrating wearable medical technology into inpatient care. She brings that frontline clinical lens to RCI, helping digital health and AI/ML clients build commercial strategies grounded in real clinician workflows.
Nikki holds a DBA and brings large-scale operations leadership from Nissan, Asurion, and Albéa Group, where she's directed enterprise system migrations, process re-engineering, and global cross-functional teams. At RCI, she applies that same project discipline to keep client engagements on time, on budget, and execution-ready.
I started RCI Global Partners after watching too many brilliant innovators burn through capital, lose momentum, or walk away — not because their science failed, but because their strategy did.
After two decades leading clinical and regulatory strategy at global MedTech and Pharma companies, I knew exactly what world-class regulatory architecture looked like. I also knew that the startups who needed it most couldn’t access it — not at big-firm prices, and not at big-firm speed.
Your mission deserves more than check-the-box compliance. It deserves traction. It deserves clarity. It deserves to change lives. That’s what we build at RCI Global Partners — a team of senior practitioners who treat your runway like it’s our own.
Because getting to market shouldn’t mean running out of money or direction.
Not ready to book a call? Explore tools and insights for founders navigating FDA strategy, clinical development decisions, and investor readiness – across devices, diagnostics, drugs, and biologics.
You’ve built something powerful. Now let’s sequence the path that brings it to patients – and to market – without preventable setbacks.
