Accelerated Turnaround
Leverage an AI-assisted workflow to reduce your documentation and submission timelines by up to 50%, getting you to market faster.
DonlonLSC
AI-Powered Global Medical Device Regulatory Support.
Fast - Secure - Powerful
Guaranteed Expert Oversight.
Why Choose Donlon LSC
Greater Traceability & Quality
Achieve superior consistency across all pillar documentation. Our process ensures a clear, traceable narrative, leading to cleaner, more robust submissions.
Expert-in-the-Loop Guarantee
Benefit from the best of both worlds. While AI handles the heavy lifting, every single output is personally reviewed and verified by a regulatory expert. No exceptions.
Lisa Donlon
Director & Lead Consultant
I provide security-conscious, AI-assisted regulatory support for Life Science companies. By integrating advanced tools with expert human review, I deliver cleaner submissions and greater traceability, reducing turnaround times by up to 50%. Your project gets the efficiency of AI and the assurance of a seasoned professional.
Security-First Approach
Your intellectual property is paramount. My workflow is built on a security-conscious framework to ensure your confidential data is always protected.
Certainty in a Complex World
Fixed-Price Regulatory Solutions
Navigate the global MedTech landscape with confidence. Our transparent, fixed-price packages, powered by expert insight and AI-driven efficiency, provide a clear path to market for your medical device or combination product.
Step 1
The Compass Assessment
$0 FREE
Is your product a medical device? A combination product? A consumer good? Before you can create a strategy, you need to know what you're working with. This free, no-obligation assessment provides the foundational clarity you need to move forward.
What you get:
- A concise report detailing the qualification and classification of one device/product family in one target market (e.g., EU or US or Australia or Japan)
Step 2
The Single-Market Blueprint
€550 SME
€1,000 Enterprise
With your classification confirmed, this package provides a detailed roadmap for market entry in a single jurisdiction. We'll outline the specific regulatory hurdles, documentation requirements, and timelines you need to anticipate.
What you get:
- A documented regulatory strategy, including key standards, submission requirements, and a high-level project timeline
Step 3
The Global Navigator
€2,275 SME
€3,750 Enterprise
Ready to scale? This offering expands your strategy across multiple markets, harmonising requirements where possible and creating an efficient, multi-jurisdictional plan.
What you get:
- Multi-Market Qualification, Classification & Strategy: a formal assessment across up to 5 key global markets with a robust global regulatory strategy that serves as your playbook for international expansion
Coming Late 2026
PraxisVerify
The secure management platform for life science expertise.
A purpose-built platform connecting medical device companies with verified regulatory experts. Secure document exchange, verified credentials, and streamlined expert engagement — all in one place.
Learn More at praxisverify.com