RCI Global Partners orchestrates your regulatory, clinical, and commercialization strategy – from first classification or indication decision to FDA engagement – so your evidence, capital, and milestones align before costly mistakes compound.
Trusted by MedTech, Biotech, and Pharma founders across the U.S. and Europe. 200+ medical innovations brought to market in 6 countries.
Moving fast without clarity is expensive. Companies that skip the architecture phase choose the wrong pathway, generate misaligned evidence, and walk into FDA interactions unprepared. The result isn’t acceleration — it’s expanded clinical burden, investor hesitation, and preventable rework. Whether you’re classifying a device or defining an indication, the first strategic decisions shape everything that follows.
RCI Global Partners helps emerging MedTech, Biotech, and Pharma companies design regulatory and clinical strategies that protect capital and compress risk. Our team brings leadership experience from Medtronic, Smith+Nephew, and Stryker — with 200+ medical innovations guided to market across six countries — aligning regulatory architecture with investor expectations, FDA realities, and market adoption strategy.
The FDA pathway for a device is not the pathway for a drug or biologic, and your strategy shouldn’t pretend otherwise. RCI Global Partners brings dedicated expertise to both.
From classification decision to clearance or approval, we architect your pathway across 510(k), De Novo, and PMA routes – defining whether you need a clinical study, structuring your Pre-Submission, and framing evidence so FDA engagement strengthens your position instead of expanding your burden.
From indication strategy to IND and beyond, we help you define the development plan investors and FDA will believe – structuring your pre-IND engagement, aligning preclinical and clinical evidence with your target label, and sequencing milestones so all funds advance a de-risked stage instead of financing uncertainty.
Book a Discovery Call We get to know your product, your stage, and your goals - then ask the questions that matter most before they cost you.
Sequence what comes next We align your goals with the right regulatory, clinical, and market pathways - defining what must be done now, what can be deferred, and how to tie milestones to funding and FDA engagement.
Control the narrative With RCI Global Partners driving execution, you validate a strategy you own - instead of letting the agency or your investors define it for you.
With RCI Global Partners, you can:
I chose RCI for our reimbursement strategy because of the unique combination of clinical research and regulatory compliance. Deep nowledge of FDA, Medicare, and Medicaid – seamlessly managed, with a positive impact on the business. I will definitely use RCI again.”
“We went from pre-submission to IRB IDE approval on the first attempt. A topic that once felt so intimidating became completely manageable.”
“Capital follows clarity. Working with RCI gave me immediate clarity on how to position for investors.” Tanja Tervonen –
“Rare professionals who can translate regulatory complexity into clear, actionable strategy – and do it in a way that actually accelerates progress. If you’re building in healthcare, medtech, or dual-use, you want them in the room early and often.”
A focused, fixed-price engagement that delivers regulatory clarity, sequenced milestones, and budget estimates – a plan you can execute against, raise against, and defend in front of FDA and investors. Most clients start here.
From Prototype to FDA Clearance: The Early Founder’s Guide to U.S. Medical Device Regulatory Strategy: A whitepaper authored by RCI Global Partners Founder and CEO Shaherah Yancy explaining the importance of a regulatory roadmap.
Every innovation needs a clear path – to the clinic, to FDA, and to the market. Whether you’re building a device or developing a therapeutic, partner with RCI Global Partners to turn your vision into a sequenced, fundable strategy.
