Strengthen Your Quality Management System, Optimize Your Regulatory Processes, and Reach ML3

From QMS implementation to final assessment readiness — we deliver
practical, tailored solutions that drive results.

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Poor QMS Is a Barrier to ML3 Success

Build a QMS that meets WHO standards — and sustains them.

Poor QMS are a Barrier to ML3 Success. Is your NRA at risk?

A poorly structured or non-compliant Quality Management System (QMS) is one of the biggest barriers to WHO ML3 certification. Many National Regulatory Authorities (NRAs) struggle with absent our outdated processes, inconsistent documentation, and weak oversight, making enforcement unpredictable and ML3 readiness difficult to achieve.
Start Your QMS Development Today

Why Choose ML3 Solution for
Your QMS Development?

  • Pre-Developed, WHO-Compliant SOPs : We offer a comprehensive library of pre developed Standard Operating Procedures (SOPs), work instructions, and process maps, designed to fast- track QMS implementation while ensuring full compliance with WHO standards.
  • Tailored to Fit Your NRA's Needs: We recognize that every NRA is unique. Our solutions are not just WHO-compliant-they are adaptable, scalable, and fully tailored to meet national regulatory requirements.
  • Data-Driven, Structured Approach: We take the guesswork out of regulatory compliance with a clear, evidence-based methodology, ensuring faster approvals, better oversight, and streamlined operations.
  • End-to-End Support from Benchmarking to Assessment: From gap analysis and roadmap development to full implementation and post-assessment support, we guide you every step of the way to ensure smooth, efficient progress toward ML3.
Start Your QMS Development Today

Get ML3-Ready with
Proven SOPs.

We provide ready-to-use, WHO-compliant SOPs and documentation that help NRAS develop, optimize, and maintain an efficient QMS You didn’t come this far to stop

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How Our QMS Development
Process Works

01
01

Assessment of Existing Systems

  • Evaluate the current QMS structure to identify gaps and inefficiencies.
  • Benchmark against WHO standards to determine compliance readiness.
02

Customization of SOPs & Manuals

  • Adapt our ready-to-use templates to align with national regulatory needs.
02
03
03

Implementation & Training

  • Support NRAs in institutionalizing SOPs for long-term regulatory sustainability.
  • Provide expert-led training to equip staff with the necessary skills.
04

Monitoring & Continuous Improvement

  • Track QMS performance using key indicators and compliance audits.
  • Refine workflows and documentation to address gaps and improve efficiency.
04

Ready to Strengthen Your Regulatory Authority?

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

Book a Free Consultation

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Faster Certification, Lower Costs, Stronger Systems



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