Innovations don't fail because they move too slowly. They fail without regulatory architecture.

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.

THE PROBLEM

You're racing the clock. Uncertainty and cost are racing you.

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.

THE SOLUTION

You Don’t Need More Consultants or a Bigger Budget. You Need Clear Regulatory Control.

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.

Two industries. One discipline: orchestrate strategy before you spend.

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.

MedTech & Diagnostics

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.

Biotech & Pharma

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.

Work With RCI in 3 Simple Steps

1 Clarity

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.

2 Strategy

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.

3 Execution

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.

At a regulatory inflection point?

With RCI Global Partners, you can:

Avoid preventable clinical expansion and regulatory rework
Enter FDA interactions - Pre-Sub or pre-IND- with strategic clarity, not uncertainty
Align capital deployment with regulatory milestones
Strengthen investor confidence through structured evidence sequencing
Build market adoption strategy alongside regulatory execution, not after approval

Years Of Experience

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Products Brought on Market

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Countries Launched In

Grace McNamara

CEO, EXI (Dublin, Ireland)

I chose RCI for our reimbursement strategy because of the unique combination of clinical research and regulatory compliance. Deep knowledge 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.”

Annika Lundstrom

CEO, ReMinded (Finland & U.S.A.)

“Shaherah Yancy was incredibly professional in our case. What stood out to me was how she not only handled the regulatory side with expertise but also took the business context into account, which made a huge difference.”

Tanja Tervonen

Cofounder & COO, Otos (Helsinki, Finland)

“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.”

Heath Naquin

VP, Government & Capital Engagement, University Science Center

Not sure what you need yet? Start with the Strategic Roadmap.

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.

Peer Into RCI Global Partner’s Regulatory Roadmap Strategy

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.

The three most expensive misconceptions first-time founders carry into this process
How to use a Pre-Submission (and why most companies skip it at enormous cost)
The difference between academic research and regulatory evidence and why it matters
Ten myths that quietly derail companies before they ever reach market
What a regulatory strategy engagement should actually deliver

Ready to begin?

Let’s Map Your Road to Market

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.

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