MedTech & BioTech Consulting for the Research Lifecycle
Regulatory & Clinical Architecture for MedTech & Biotech
When your regulatory strategy determines your valuation, timeline, and clinical burden, execution isn’t enough. RLS structures the pathway that protects your capital and positions you to win with FDA.
Startups don’t fail because they move too slowly. They fail because they move without regulatory architecture. From first classification decision to FDA engagement, RLS ensures your regulatory, clinical, and commercialization strategy are sequenced correctly — before costly mistakes compound.
Trusted by Industry Leaders
You're Racing Against Time, But Uncertainty and Cost Slows You Down
Moving fast without clarity is expensive! Without a clear roadmap and accurate sequencing, companies 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. The first strategic decisions shape everything that follows.
You Don’t Need More Consultants or a Bigger Budget. You Need Clear Regulatory Control.
RLS helps emerging MedTech and biotech companies design regulatory and clinical strategies that protect capital and compress risk. Founder Shaherah Yancy has led global commercialization across more than 200 medical innovations, aligning regulatory architecture with investor expectations, FDA realities, and market adoption strategy.
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
Sequence What Comes Next
We’ll align your goals with the right regulatory, clinical, and market pathways - defining what must be done, what must be deferred, and how to align milestones with funding and FDA engagement.
3
Execution
Control the Narrative
With RLS driving execution, we ensure you are validating a strategy you own - not asking the agency or investors to define it for you.
The Right Strategy Saves You More Than Time. It Protects Your Valuation.
With RLS, you can:
- Avoid preventable clinical expansion and regulatory rework
- Enter FDA interaction 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
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.