Guiding National Regulatory Authorities through every step of
the ML3 journey.
A Team of Regulatory Experts with Real-World Impact
ML3 Solutions is a specialized consulting firm dedicated to strengthening National Regulatory Authorities (NRAs) in their journey toward WHO Maturity Level 3 (ML3) recognition. Our team is made up of seasoned professionals — including former regulators, policy advisors, and quality management specialists — who have successfully supported WHO assessments, regulatory reforms, and capacity-building initiatives across Africa.
With deep knowledge of the WHO Global Benchmarking Tool (GBT) and hands-on implementation expertise, we offer practical, high-impact support that empowers NRAs to build efficient,
WHO-compliant systems — and sustain them.
Strengthening Regulatory Systems for Better Health Access
At ML3 Solutions our mission is to support National Regulatory Authorities in building strong, transparent, and WHO-compliant regulatory systems. We deliver tailored guidance, practical tools, and expert-led implementation to help NRAs reach Maturity Level 3 — accelerating access to quality-assured medical products and strengthening public health systems across Africa and beyond.
A Future Where Every NRA Meets Global Standards
A future where every country has a strong, trusted regulatory authority ensuring access to safe, effective, and quality medical products.
We envision a world where all National Regulatory Authorities operate at globally recognized standards, empowered by the right tools, expertise, and systems to protect public health and foster innovation.
Our vision is grounded in equity and sustainability: where National Regulatory Authorities (NRAs) operate with transparency, consistency, and confidence, fully aligned with international benchmarks like the WHO Global Benchmarking Tool (GBT).
By empowering NRAs with the right tools, expert support, and practical strategies, we believe in building a future where strong regulatory systems protect public health, encourage local innovation, and foster global trust in health systems.
What Drives Us
We operate with transparency, honesty, and ethical responsibility—building trust with every partner and stakeholder we support.
Our solutions are grounded in deep regulatory experience and global health knowledge, delivered by professionals who have worked directly with WHO and NRAs across the world.
We believe in co-creation. We work collaboratively with NRAs, tailoring solutions that reflect local realities while aligning with international standards.
We focus on actionable, ready-to-use solutions that drive measurable results—whether it’s a new legal framework, a compliant QMS, or a trained regulatory workforce.
Our ultimate goal is to strengthen health systems and improve access to safe, effective, and quality medical products through sustainable regulatory capacity
Built on Experience. Focused on Results.
ML3 Solutions empowers National Regulatory Authorities (NRAs) to achieve WHO Maturity Level 3 (ML3) recognition through strategic, hands-on support. With a team of former regulators, policy advisors, and quality management specialists, we provide tailored solutions to strengthen regulatory frameworks, enhance oversight, and accelerate access to safe, quality-assured medical products.
Our expertise spans regulatory gap assessments, legal framework development, Quality Management System (QMS) implementation, and workforce capacity building, ensuring NRAs meet globalstandards efficiently and sustainably. Backed by a proven track record and WHO-aligned methodologies, ML3 Compliance Solutions delivers practical, cost-effective pathways to ML3 compliance, helping NRAs build resilient, internationally recognized regulatory systems that support public health and innovation.
Let’s talk about how we can help your NRA reach ML3 status faster and more efficiently.
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