Partner with regulatory experts to fast-track your path to WHO Maturity Level
3 with tailored, hands-on solutions.
At ML3 Solutions, we specialize in helping National Regulatory Authorities (NRAs) achieve WHO Maturity Level 3 (ML3) recognition. Our work strengthens regulatory systems through tailored strategies, practical implementation, and expert training.
Our team of regulatory experts, former assessors, and quality systems specialists delivers practical, results-oriented solutions—from legal framework reform and QMS development to GBT benchmarking and final assessment readiness.
Our hands-on approach ensures that NRAs build sustainable, WHO-compliant regulatory systems that
enhance oversight, accelerate access to quality-assured health products, and strengthen public trust.
Regulatory Solutions Designed for Impact
At ML3 Solutions, we bring deep regulatory insight, real-world implementation experience, and a singular focus on helping NRAs reach WHO Maturity Level 3. Our team includes former regulators, policy advisors, and quality experts who’ve worked hands-on with WHO GBT assessments and health system strengthening across Africa
Supporting Francophone and Anglophone Countries Across Africa
At ML3 Solutions, we proudly serve National Regulatory Authorities (NRAs) and Regional Economic Communities (RECs) across both Francophone and Anglophone Africa.
Our multilingual team of regulatory experts brings deep contextual knowledge, cultural understanding, and bilingual support to ensure our solutions are practical, relevant, and fully adaptable to your national systems.
A Structured, Results-Driven Path to ML3
We will assist you in conducting a WHO GBT-aligned self-benchmarking to evaluate your NRA true maturity level, identify compliance gaps, and assess operational needs. Using this data, we will develop a customized Institutional Development Plan with a clear roadmap for ML3
We work with NRAs to develop and/or revise policies, laws, and regulatory guidelines aligned with WHO and international best practices. Our pre-developed regulatory templates and expert guidance streamline the process, ensuring efficient adoption and enforcement
A WHO-compliant Quality Management System (QMS) is essential for regulatory consistency and operational efficiency. We provide ready-to-use SOPs, work instructions, and quality manuals and train regulatory teams to fully integrate QMS into daily operations.
We conduct mock and readiness assessments, and compliance checks to ensure full preparation for the WHO ML3 evaluation. Our experts assist in validating WHO GBT documentation and structuring all necessary proof of implementation.
Faster Certification, Lower Costs, Stronger Systems
Our structured approach reduces certification time by up to 50-70%, ensuring NRAS meet WHO standards efficiently.
By using ready-to-use SOPs, QMS templates, and regulatory frameworks, NRAs can significantly cut costs and successfully scale improvements.
We provide comprehensive, step-by-step support, from benchmarking to final WHO assessment preparation.
Our team has firsthand experience in WHO compliance evaluations, ensuring NRAs receive actionable, high-impact solutions.
Let’s talk about how we can help your NRA reach ML3 status faster and more efficiently.
Faster Certification, Lower Costs, Stronger Systems
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