ML3 Solutions supports Regional Economic Communities in building harmonized, WHO-aligned regulatory systems by leveraging shared tools, policies, and cross-REC best practices.
RECs play a critical role in facilitating the free movement of medicines, strengthening supply chain resilience, and ensuring consistent regulatory oversight across borders.
By building strong, harmonized systems, RECs accelerate access to safe, effective, and quality-assured health products — while reducing duplication and costs
Support RECs in defining a clear, coordinated strategy for regulatory harmonization.
Align national priorities with regional policy objectives and continental frameworks.
Assist in reviewing and adapting national regulations to support mutual recognition, joint assessments, and shared standards.
Provide model legislation, regulatory templates, and policy guidance for regional use.
Deliver joint training programs, workshops, and regulatory exchanges to promote peer learning.
Develop regional centers of excellence and knowledge-sharing platforms.
Design regional quality management systems (QMS) and tools that support consistent decision-making.
Establish integrated data platforms for regulatory tracking, reporting, and transparency.
Support the REC Secretariat in managing technical working groups and regional assessment committees.
Facilitate the development of regional guidelines and procedures for registration, pharmacovigilance, and inspection.
A Structured, Step-by-Step Approach to Regional Integration
Experts in Regional Regulatory Harmonization
With years of experience supporting regional platforms, ML3 Solutions brings a deep understanding of continental strategies, REC-specific challenges, and the technical know-how to deliver harmonized systems that work across borders. We’ve supported legal convergence, regional QMS, and joint capacity-building across multiple African RECs.
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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