ML3 is a designation given by the World Health Organization (WHO) to National Regulatory Authorities (NRAs) that meet a defined level of regulatory functionality and performance. Reaching ML3 means an NRA is operating at a stable, well-functioning level and is recognized globally as capable of performing core regulatory functions independently and reliably.
We provide end-to-end support, from conducting self-benchmarking using the WHO Global Benchmarking Tool (GBT) to developing Institutional Development Plans (IDPs), strengthening legal and regulatory frameworks, implementing WHO-compliant Quality Management Systems (QMS), building workforce capacity, and preparing for the final WHO assessment through mock audits and documentation support.
Yes. We support RECs in designing and implementing Medicines Regulatory Harmonization (MRH) programs aligned with AUDA-NEPAD, the African Medicines Agency (AMA), and existing initiatives from other RECs. Our services include legal alignment, strategy development, joint training programs, and operational coordination support.
Absolutely. We offer a suite of ready-to-use SOPs, legal templates, QMS frameworks, and training modules that can be fully adapted to your national or regional context. Customization ensures relevance, compliance, and ownership by your regulatory teams.
The timeline varies by country and existing capacity, but with our structured approach and pre-built resources, NRAs often reduce their ML3 journey time by up to 50%. We help eliminate delays through targeted planning, proven tools, and efficient implementation support.
We offer both. Our team provides on-site technical assistance, remote workshops, virtual mentoring, and document reviews. We adapt our delivery based on the needs, resources, and preferences of each NRA or REC.
Our team includes former WHO assessors, experienced regulators, legal advisors, and quality management specialists. Many have played key roles in guiding NRAs to ML3 recognition and in leading or supporting WHO GBT evaluations and training across Africa.
Simply reach out to us via our Contact Us form or email. We’ll schedule an initial consultation to understand your needs and recommend a tailored support plan based on your NRA or REC’s current stage in the ML3 journey.
We offer a variety of tailored training programs covering all key regulatory functions (e.g. registration, pharmacovigilance, inspection, clinical trials, laboratory oversight, and more). These include workshops, secondments, on-the-job training, virtual courses, and Training of Trainers (ToT) modules—all designed to build practical regulatory expertise.
Yes. We guide NRAs through self-benchmarking using the WHO GBT and support the development of realistic, structured IDPs that align with WHO recommendations and national priorities. We also help define milestones, resource needs, and implementation strategies.
We offer customizable templates for laws, regulations, and guidelines. Our experts work directly with national legal teams and policymakers to adapt these frameworks and ensure they align with WHO standards, national legislation, and regional harmonization efforts
Absolutely. Our goal is not just to help you achieve ML3, but to help you sustain and continuously improve your regulatory system. We offer post-certification support, including system reviews, refresher training, continuous QMS improvement, and help with upcoming WHO re-assessments.
Yes. We regularly collaborate with development partners, donors, and global health organizations to deliver technical assistance, conduct benchmarking missions, and strengthen regulatory systems at both national and regional levels.
We primarily work across Africa, with a focus on countries and RECs aiming to strengthen their regulatory capacity in alignment with WHO and African Union initiatives. However, our solutions are adaptable and can be extended to other LMICs upon request.
A typical engagement may include:
Let’s talk about how we can help your NRA reach ML3 status faster and more efficiently.
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