RCI Global Partners designs the regulatory, clinical, and commercialization architecture that determines how your capital is deployed, how your evidence is sequenced, and how your product enters FDA interaction. Whether you’re headed for 510(k), De Novo, or PMA – or pre-IND through NDA – your pathway should be deliberate, not reactive.
If any of these describe you, you’re at a strategic inflection point – and architecture matters most right now:
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.
Classification, 510(k)/De Novo/PMA strategy, Pre-Submissions, IDE studies, EU MDR/IVDR, Health Canada.
Indication strategy, pre-IND/IND, NDA pathways, clinical development sequencing, combination products.
Not sure what you need yet? Most founders aren’t. The Strategic Roadmap is a focused, fixed- price engagement that delivers regulatory and clinical clarity, development milestones, go-to-market strategy, and budget estimates – a sequenced plan you can execute against, raise against, and defend in front of FDA and investors.
Your regulatory pathway isn’t a box to check – it’s your business strategy. The smartest companies work backwards: aligning regulatory choices with commercial goals to pick the right pathway, not just a pathway.
Medical Devices: Q-Sub/Pre-Submission strategy and lead negotiation; market applications including 510(k), De Novo, PMA; Breakthrough Device Designation requests
Pharmaceuticals & Biologics: Pre-IND (PIND) strategy and meetings; INDs and NDAs.
Devices & Diagnostics: Market applications under EU MDR and IVDR; Notified Body selection, preparation, and negotiation.
Medical Devices: Health Canada navigation and market applications (including ITAs on the
clinical side).
At every step, we bridge product innovation and regulatory approval – so you build traction while we handle the complexity.
It’s not about collecting more data. It’s about collecting the right data, at the right time, for the right audience- FDA, payers, providers, and investors. Clinical evidence creates believers in your product.
Every study we design serves three audiences at once: the regulator who clears you, the market that adopts you, and the investor who funds the next stage.
Regulatory approval doesn’t guarantee revenue. Approval is the starting line – and market adoption shouldn’t be a post-approval scramble. We design it into your regulatory and clinical strategy from day one, so the evidence you generate for FDA also sells to hospitals, payers, and providers.
Executive-level regulatory, clinical, and commercial leadership – without full-time C-suite overhead. For companies that don’t yet have in-house regulatory, clinical, or quality teams, RCI Global Partners acts as your embedded function: fractional leadership, SME advisory, and ongoing strategic counsel.
Advisory engagements start with a flexible 15-hour-per-month retainer (3-month minimum), giving you on-demand access to senior consultants – ACRP-certified clinical scientists, PMP-certified program managers, and regulatory experts with advanced degrees.
Every engagement starts the same way: a free discovery call where we assess your position and tell you honestly which model fits – including when you don’t need us yet.
Fixed-price, fixed-scope. Your sequenced plan in weeks. The default starting point.
Milestone-based execution: submissions, study design and management, market access projects. Flat-rate packages available for common scopes (e.g., regulatory submissions, investor readiness).
Ongoing fractional leadership from 15 hours/month.
“I’ve been working with RCI Global Partners for about a year on our FDA regulatory work. Knowledgeable, responsive, and effective.”
“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.”
Find answers to the questions we hear most often about our services and engagement process.
Yes – every engagement starts with a free discovery call.
Yes. RCI Global Partners operates two practice areas: Device Development & Commercialization and Drug Development & Commercialization.
RCI Global Partners works with startups and emerging companies. We also work with large organizations on defined programs.
Yes, our consultants are ACRP-certified clinical scientists, PMP-certified program managers, regulatory experts with advanced degrees (PhD, PharmD, MS), and MBAs on the business side.
The Strategic Roadmap is fixed-price. Projects are milestone-based with flat-rate packages for common scopes. Retainers start at 15 hours/month. Every proposal is tailored on a discovery call.
Every week spent second-guessing your strategy is a week lost on funding, traction, or approvals. Start with a discovery call.
