We Help NRAs Achieve WHO ML3 With Confidence

We provide expert-led regulatory strengthening, training, and hands-on implementation support to fast-track your ML3 journey.

Our Services

ML3 Solutions provide expert-driven, structured services to help National Regulatory Authorities (NRAs) strengthen their regulatory systems, ensure compliance, and achieve WHO Maturity Level 3 (ML3) recognition. With ready to use regulatory frameworks, hands-on implementation support, and expert-led training, we empower NRAs to streamline their ML3 recognition journey and build sustainable regulatory systems that ensure timely access to safe, effective, and high-quality medical products.

WHO GBT Self-Benchmarking & IDP Development

Comprehensive assistance to conduct self-benchmarking following WHO GBT requirements, IDP generation, and framework implementation tailored to your needs.
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Legal & Regulatory Framework Strengthening

Ready-to-use and customizable legal and regulatory text aligned with WHO ML3 requirements for effective regulatory compliance and quality management.
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ML3 Compliant Quality Management System Development

Fully developed ML3-compliant QMS that includes pre-developed SOPs, process maps, and quality manuals, ensuring consistency, transparency, and efficiency in regulatory processes.
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Regulatory Capacity-Building & Training

Tailored capacity-building programs covering seven key regulatory functions, designed to strengthen the expertise of regulatory staff. Our approach includes workshops, hands-on training, and mentorship.
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WHO ML3 Final Assessment Readiness

Comprehensive support for the WHO ML3 final assessment. Our services include mock audits, readiness assessments, and targeted recommendations. We also assist in completing the WHO GBT tools, ensuring accuracy for a successful evaluation.
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Support to Regional Economic Communities

ML3 Compliance Solutions supports Regional Economic Communities in building harmonized, WHO-aligned regulatory systems by leveraging shared tools, policies, and cross-REC best practices.
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Ready to Strengthen Your Regulatory Authority?

Let’s talk about how we can help your NRA reach ML3 status faster and more efficiently.

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Faster Certification, Lower Costs, Stronger Systems



    Contact US For Support

    Reach out for tailors regulatory solutions and support for achieving WHO ML3 compliance. We’re here to assist you every stop of the way.



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