Our Services

End-to-end execution across African markets.

Lepaz Africa offers four integrated services — from regulatory strategy and coordinated local execution through to market entry planning and regulatory intelligence. Each service is available independently, but they work best together.

Device typesMedical DevicesIVDsDigital healthPoint-of-Care DiagnosticsHospital EquipmentCapital equipment

How We Work

Strategy without execution is just advice.

Many consultancies will tell you which markets to enter and which regulatory pathway to follow. Lepaz Africa goes further — we coordinate in-country regulatory specialists, manage the submissions, and stay engaged through approval and beyond. Our model is built for manufacturers who need a reliable, accountable partner, and a single point of contact across multiple African markets.

We work with manufacturers from across the world — European, North American, Asian, and beyond. Whatever the product category, whatever the target market, we bring the same structured approach: clear regulatory strategy, coordinated local execution, and a single point of contact throughout.

Device types we support.

We support a wide range of medical technologies, including medical devices, in vitro diagnostics (IVDs), digital health technologies, point-of-care diagnostics, hospital equipment, and capital equipment.

If you are unsure whether your product falls within our scope, get in touch — we will let you know.

At a glance

Compare our four services side by side

Regulatory Strategy & Filing

Every African market has its own regulatory authority, its own classification system, and its own approval process. Getting the strategy right from the start is what separates a smooth registration from a costly delay.

What this includes

Country-specific regulatory pathway analysis for each target market
Device classification guidance aligned to national and IMDRF frameworks
CE Mark and FDA clearance reliance pathway identification and optimisation
Technical dossier review and documentation preparation
Submission coordination through our network of vetted in-country regulatory specialists
EAC harmonisation strategy — leveraging frameworks to support broader East African market access
Post-submission query management and authority liaison
Renewal and post-market surveillance planning

Typical outputs

Regulatory pathway report per target market
Device classification confirmation and documentation checklist
Submission roadmap with realistic timelines and milestones
Dossier gap analysis and preparation guidance
Reliance pathway optimisation recommendation

Multi-country filingCE & FDA reliance pathwaysEAC harmonisationDossier preparation

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Market Entry Strategy

Regulatory approval opens the door. A market entry strategy determines what you do once you are through it. African healthcare markets vary significantly in structure, procurement dynamics, and competitive landscape.

What this includes

Target market prioritisation and sequencing based on device category, regulatory maturity, and commercial opportunity
Public vs. private sector entry analysis for each market
Competitive landscape mapping — identifying existing products, pricing benchmarks, and market gaps
Healthcare infrastructure and procurement channel assessment
Pricing and positioning recommendations tailored to each market’s structure
Go-to-market planning aligned to regulatory approval timelines
Identification of institutional buyers, hospital networks, and distribution channels

Typical outputs

Market prioritisation report with rationale for entry sequencing
Competitor landscape overview per target market
Public vs. private sector entry recommendation
Pricing benchmarks and positioning guidance
Go-to-market recommendations aligned to regulatory timeline

Market prioritisationSector mappingPricing & positioningGo-to-market planning

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Regulatory Coordination & Local Execution

Most African regulatory authorities require local representation and in-country regulatory support. Lepaz Africa engages, coordinates, and oversees vetted local regulatory specialists on your behalf, providing a single point of contact.

What this includes

Identification and vetting of qualified in-country regulatory specialists across all six active markets
Coordination of local regulatory expertise, scope definition, and project mobilisation
Ongoing coordination of local regulatory activities and stakeholder communication
Coordination of all submission-related communication and documentation exchange
Commercial oversight — you are kept informed of all key milestones and decisions
Oversight of local execution and progress monitoring throughout the registration process
Support for local representation requirements across Nigeria (NAFDAC), Kenya (PPB), South Africa (SAHPRA), Egypt (EDA), Ethiopia (EFDA), and Botswana (BoMRA)

Typical outputs

Local regulatory engagement plan and project coordination structure
Defined local support scope and implementation roadmap
Ongoing communication and milestone reporting throughout submission
Escalation management if issues arise during the process

Partner vettingLocal representationMilestone reportingEscalation management

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Regulatory Intelligence & Harmonisation

Regulatory requirements across Africa are evolving rapidly. Manufacturers that understand those changes early can make better market access decisions and position themselves ahead of competitors.

What this includes

Ongoing monitoring of regulatory developments across all six active markets and key regional bodies
Tracking of AMA treaty ratification progress and medical device inclusion developments
EAC, SADC, and ECOWAS harmonisation updates relevant to your target markets
Identification of emerging reliance pathways and fast-track mechanisms as they become available
Intelligence on national regulatory authority maturity developments — including EFDA’s WHO Maturity Level 3 achievement
Monitoring of regulatory stakeholder developments and identification of opportunities to support capacity building
Strategic advisory on positioning ahead of regulatory shifts that affect market access

Typical outputs

Quarterly regulatory intelligence briefing covering all six active markets
AMA and regional harmonisation update notes as developments occur
Emerging reliance pathway alerts relevant to your device and markets
Strategic advisory note on positioning and timing recommendations
Regulatory authority maturity update where relevant to your submission

Regulatory monitoringAMA & harmonisation trackingReliance pathway alertsStrategic advisory

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Getting Started

From first conversation to first submission.

1. Initial conversation

We start with a focused discussion about your device, your target markets, and your timeline. No forms, no jargon — just a practical conversation to understand what you need and whether Lepaz Africa is the right fit.

2. Scoping and proposal

Based on the conversation, we prepare a clear scope of work covering the services, markets, timelines, and investment required. We identify the appropriate regulatory pathway and coordinate the local expertise needed to support execution.

3. Execution and updates

Once agreed, we begin. You have a named point of contact at Lepaz Africa throughout. We provide regular updates, flag any issues early, and keep the process moving so you do not have to chase.

Not sure which service you need? Let’s start with a conversation.

Most manufacturers come to us with a specific market or regulatory challenge in mind. We help scope what is needed and recommend the right combination of services for your situation — at no obligation.

Get in Touch

Lepaz Africa BV · The Hague, Netherlands · info@lepazafrica.com

End-to-end execution across African markets.

Strategy without execution is just advice.

Device types we support.

At a glance

Regulatory Strategy & Filing

Market Entry Strategy

Regulatory Coordination & Local Execution

Regulatory Intelligence & Harmonisation

Getting Started

From first conversation to first submission.

1. Initial conversation

2. Scoping and proposal

3. Execution and updates

Not sure which service you need? Let’s start with a conversation.

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