Areas of Expertise

Our Sectors

Four specialized domains where deep regulatory knowledge meets practical East African market experience.

Medical devices
PPB Regulated
Class A–D All risk classes covered
Regulatory docs
Medical compliance
Medical Devices

Navigating Kenya's Medical Device Landscape

We don't just navigate regulations — we master them. As a trusted partner in Kenya's healthcare ecosystem, we specialize in regulatory affairs for medical devices, ensuring innovation meets compliance seamlessly. Our team covers all risk classes — from Class A devices to high-risk Class D implantables.

Device classification (PPB / GHTF)
Technical dossier preparation
ISO 13485 gap analysis
PPB registration & renewal
Post-market surveillance
IVD device registration
Adverse event reporting
Import permits & distribution
AuthorityPPB Kenya
StandardsISO 13485 · GHTF
Timeline3–18 months
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Pharmaceuticals
WHO GMP Aligned
EAC Region 5-country coverage
Pharma lab
Medicine capsules
Pharmaceuticals

Pharmaceutical Market Access Across East Africa

We provide end-to-end regulatory support for pharmaceutical companies seeking to register and commercialize products in Kenya and across East Africa. Whether you are a local manufacturer, an international brand, or a distributor managing an existing portfolio, our specialists provide tailored guidance at every stage.

PPB product registration
CTD / ACTD dossier preparation
GMP compliance assessment
Variation & renewal management
Pharmacovigilance setup
Import & export permits
Bioequivalence guidance
EAC harmonization support
AuthorityPPB Kenya
StandardsWHO GMP · ICH CTD
Timeline6–24 months
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Food supplements
KEBS Certified
2–8 mo Typical approval timeline
Natural supplements
Nutritional products
Food Supplements

Bringing Nutraceuticals to Market Legally

Food supplements, nutraceuticals, and fortified food products require registration and approval from KEBS before they can be legally marketed in Kenya. Navigating KEBS, KEPHIS, and relevant authority requirements can be complex — Marsland simplifies this with complete end-to-end management from formulation review to shelf approval.

Regulatory pathway mapping
KEBS Standards Mark support
KEPHIS phytosanitary compliance
Nutritional label compliance
Health claim substantiation
Novel ingredient safety review
Import/export documentation
Stability study guidance
AuthorityKEBS · KEPHIS
StandardsKS 1700 · Codex
Timeline2–8 months
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Cosmetics
KPRA Notified
1–6 mo Notification & approval
Skincare
Cosmetics compliance
Cosmetics

Cosmetics Compliance — Beauty Meets Regulation

Cosmetic products in Kenya are regulated under the Kenya Cosmetics Regulation, overseen by KPRA and aligned with EAC Cosmetics Regulations. All cosmetics — from skincare and haircare to makeup and fragrances — must be notified before market entry. Our team ensures your products enter the market and remain fully compliant throughout their lifecycle.

EAC Cosmetics notification
KPRA registration management
Cosmetic Safety Report (CSR)
INCI ingredient list review
Restricted substances screening
Label & claim compliance
Preservative challenge testing
Product Information File (PIF)
AuthorityKPRA · PPB · EAC
StandardsEAC · ISO 22716
Timeline1–6 months
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Which sector applies to your product?

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