Consulting & Roadmapping
Strategy, scoping, and pilot planning that turn health innovation ideas into practical, IRB-ready programs and technology roadmaps.
Services
Regulatory & Compliance Advisory
Navigate FDA, EFDA, and WHO expectations with clear regulatory mapping, compliance readiness, and governance support.
Overview
About Regulatory Advisory
Bringing a health product, study, or digital tool into African markets means working across several regulatory frameworks at once. Requirements from the U.S. Food and Drug Administration (FDA), the Ethiopian Food and Drug Authority (EFDA), and World Health Organization (WHO) guidance overlap in some places and diverge in others.
Our regulatory advisory team helps you see that landscape clearly, prepare the documentation it calls for, and put policies and governance in place that stand up to review. The goal is fewer surprises, faster decisions, and compliance that is built in rather than bolted on.
Challenges addressed
The problems we help you solve
Fragmented requirements
Multiple authorities, each with their own pathways, timelines, and documentation standards.
Limited local regulatory insight
Global teams often lack practical knowledge of how submissions are reviewed in African markets.
Late-stage compliance gaps
Issues discovered close to submission or launch are slower and more costly to fix.
Evolving guidance for digital health
Expectations for software, AI, and data-driven tools continue to change across jurisdictions.
Capabilities
How we support you
Specialized support across the full scope of Regulatory Advisory.
FDA, EFDA, and WHO regulatory mapping
Side-by-side analysis of applicable pathways, requirements, and timelines across authorities.
Compliance readiness
Gap assessments against relevant standards with a prioritized, practical remediation plan.
Regulatory documentation
Support preparing, structuring, and reviewing dossiers, protocols, and supporting documents.
Policy development
Internal policies and standard operating procedures that reflect regulatory expectations.
Ethics and governance advisory
Frameworks for ethical oversight, data governance, and accountable decision-making.
Our approach
A structured, collaborative process
- 1
Assess
Understand your product, study, or program and the jurisdictions it must satisfy.
- 2
Map
Chart applicable requirements, pathways, and dependencies across authorities.
- 3
Prepare
Close gaps and build the documentation, policies, and governance needed for review.
- 4
Sustain
Maintain readiness as guidance evolves and your program grows into new markets.
Benefits
What you can expect
Clarity across jurisdictions
One coherent view of what each authority expects.
Reduced submission risk
Fewer gaps and rework late in the process.
Stronger governance
Policies and oversight that support ethical, defensible decisions.
Local and global alignment
Requirements interpreted with both international and local context.
Related services
Explore related services
Regulatory & Ethics Support
Regulatory strategy, submissions, and ethics committee coordination that keep your study compliant and participants protected.
Capacity Building
Workforce, institutional, and regulatory capacity strengthening that leaves research and health systems stronger long after a project ends.
Let's talk about Regulatory Advisory
Tell us about your goals and we will help you identify the right next step.