MedTech & BioTech Consulting for the Research Lifecycle
Accelerating Market Access for Emerging MedTech & Pharma
From early-stage strategy to post-approval execution, RLS helps you navigate commercialization, regulatory hurdles, and clinical pathways—with startup-friendly rates and expert guidance at every phase.
Shaherah Yancy, Founder and CEO
Trusted by Industry Leaders
You're Racing Against Time—But Uncertainty and Cost Slows You Down
Without a clear commercialization roadmap, you risk choosing the wrong regulatory pathway, running unnecessary or misaligned studies, and missing critical investor or approval milestones.
In MedTech and Pharma, moving fast without strategy doesn’t accelerate success—it leads to stalled approvals, wasted capital, and lost market opportunities.
You Don’t Need a Bigger Budget. You Need a Smarter Strategy.
RLS helps early-stage MedTech and Pharma companies design regulatory, clinical, and market access strategies that fit startup constraints. Founder Shaherah Yancy has led global commercializations for over 200 medical innovations across the US, Canada, and Europe. and knows how to align your resources with the right regulatory pathway, clinical evidence, and investor expectations.
1
Clarity
Schedule a Clarity Call
We’ll get to know your product, challenges, and goals - then we’ll uncover the questions that matter the most to you.
2
Strategy
Get Your Strategic RoadMap
We’ll align your goals with the right regulatory, clinical, and market pathways—creating a tailored commercialization plan and go-to-market model.
3
Execution
Move Forward With Confidence
With RLS driving execution, you’ll accelerate your journey, pitch with clarity, and stop second-guessing what the FDA or investors expect.
The Right Strategy Saves You Time, Money, and Momentum
With RLS, you can:
- Avoid over 50% of unnecessary costs
- Accelerate time-to-market by aligning key milestones with regulatory and market expectations
- Win investor confidence with a credible, data-driven commercialization plan
- Eliminate guesswork from FDA 510(k), De Novo, and PMA submissions
- Drive revenue with market adoption strategies, not just regulatory approvals
What our clients say
“I'd choose Shaherah Yancy any day. We've worked with her for less than a year and went from pre-submission to IRB IDE approval on the first attempt! She made a topic that once felt so intimidating, completely manageable.”
Annika Lundstrom
CEO, ReMinded (Finland & U.S.A.)
“I chose RLS to work on our reimbursement strategy because of the unique combination of clinical research and regulatory compliance. The experience and knowledge of FDA, medicare and medicaid was extremely helpful. The project was seamlessly managed and the outcome was a positive impact on the business. I will definitely use RLS again!”
Grace McNamara
CEO, EXI (Dublin, Ireland.)
“ Shaherah Yancy with Research Lifecycle Solutions. I’ve been working with her for about a year on our FDA regulatory work. She’s knowledgeable, responsive and effective.”
Joseph Nounou, MD
CEO, Auros Pharma (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)
"Capital follows clarity. Working with Shaherah gave me immediate clarity on how to better position my pitch for investors. If you’re looking to break through the fundraising fog and build real momentum, Shaherah is the strategic partner you need.”
Mario Sierra
CEO, Harmon IQ Biosciences (U.S.A.)
Our Services
Your innovation deserves more than a one-size-fits-all approach. With RLS, you choose the next step that fits your journey—whether that’s hands-on execution, deeper insights, or a voice that sparks investor confidence.
Strategy Services
Speaking & Workshops
Insights & Resources
Not Sure how to choose a regulatory path or If You Need a Clinical Trial?
FDA Classification & Clinical Trial Assessment
Take our 5-minute FDA Classification & Clinical Trial Assessment to find out your medical device’s likely classification, market pathway, and whether a study is necessary.
Because Medical Innovation Shouldn’t Fail for the Wrong Reasons
I started RLS 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 decades leading clinical and regulatory strategy at global MedTech and Pharma giants, I knew startups needed access to that same caliber of expertise,but at a speed and cost that made sense.
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 together.
Because getting to market shouldn’t mean running out of money or direction.
— Shaherah Yancy, Founder & CEO
“Speed means nothing if you don’t know where you’re headed”
Meet Shaherah Yancy
With 20+ years of experience guiding medical device companies through global approvals and clinical trials, Shaherah brings a rare blend of being a scientist, business acumen, certified project manager and a certified clinical researcher. She’s built her career on strategic insight and powerful execution. Her mission? Help life science innovators and CEOs to stop flying blind and start executing with confidence.
Ready To Begin?
Let’s Map Your Road to Market
Every innovation needs a clear path. Partner with RLS to turn your vision into a viable strategy—ready for the clinic and the market.