Product registration
Preparation, review and submission of registration dossiers, and management of authority queries until approval.
- CTD / eCTD dossiers
- Device technical documentation
- Renewals and variations
Regulatory affairs & market access · East Africa
Bring safe, compliant health products to East African markets.
Gold Health Consulting guides manufacturers, importers and distributors of medicines, medical devices, cosmetics and food through registration, GMP compliance and post-market obligations, from Addis Ababa to the wider region.
- MedicinesHuman pharmaceuticals
- Medical devicesIncluding IVDs
- CosmeticsPersonal care products
- FoodFood & supplements
Services
Regulatory support from first assessment to life on the market
Choose a single service or a full market-entry package. We scope each engagement to your product, your target countries and your timelines.
Medical device & IVD compliance
Risk classification, essential principles checklists and technical file review for devices and diagnostics.
- Classification by risk class
- Clinical evidence summaries
- Labelling and IFU review
GMP & quality systems
Readiness support for manufacturers facing authority inspections, locally or abroad.
- Gap assessments and mock inspections
- ISO 13485 and WHO GMP alignment
- CAPA planning and site master files
Vigilance & post-market surveillance
Systems that keep your products compliant once they reach patients and consumers.
- Adverse event and incident reporting
- PSURs and periodic reports
- Field safety corrective actions and recalls
Local representation
Acting as your in-country contact with the regulator, where local requirements allow.
- Local agent / authorized representative
- Correspondence and follow-up
- Regulatory intelligence updates
Import, labelling & GDP
Practical support for importers and distributors moving regulated products through the supply chain.
- Import permits and pre-import checks
- Label and artwork compliance
- Good distribution & storage practice
Food & cosmetics
Registration and notification of food, supplements and cosmetic products, with the standards behind them.
- Product notification and registration
- Ingredient and claims review
- HACCP and ISO 22000 readiness
Training for industry
Practical workshops for your regulatory, quality and supply-chain teams.
- GMP, GDP and QMS fundamentals
- Dossier writing
- Vigilance and complaint handling
Industries
One partner for every regulated health product
Each sector follows different rules and authorities. We bring the right specialists to each.
Pharmaceuticals
Generic and innovator medicines, from dossier to post-approval changes.
ICH CTD · WHO GMP · PSUR
Medical devices & IVDs
Equipment, consumables and diagnostics across all risk classes.
IMDRF · ISO 13485 · ISO 14971
Cosmetics
Skin, hair and personal care products, including ingredient and claims review.
Notification · labelling · GMP
Food & supplements
Processed foods, supplements and specialized nutrition products.
HACCP · ISO 22000 · Codex
Markets
Regulators we work with across the region
Every country has its own authority, procedures and fees. We plan multi-country submissions so that one well-prepared dossier serves several markets.
| Code | Country | Medicines & devices | Food & cosmetics |
|---|---|---|---|
| ET | Ethiopia | EFDA | EFDA |
| KE | Kenya | Pharmacy and Poisons Board | Kenya Bureau of Standards |
| TZ | Tanzania | TMDA | Tanzania Bureau of Standards |
| UG | Uganda | National Drug Authority | Uganda National Bureau of Standards |
| RW | Rwanda | Rwanda FDA | Rwanda FDA (processed food, medicated cosmetics) |
| BI | Burundi | ABREMA | ABREMA |
| SS | South Sudan | Drug and Food Control Authority | Drug and Food Control Authority |
Support for Somalia, Djibouti, Eritrea and the DR Congo is available on request.
EAC
EAC harmonization
Joint assessment procedures under the East African Community medicines regulatory harmonization programme can reduce duplicate reviews.
IGAD
Horn of Africa
We follow regional harmonization work across IGAD member states, including Ethiopia, Djibouti and Somalia.
AMA
African Medicines Agency
We track continental developments under the African Medicines Agency and what they mean for your registration strategy.
Regulatory library
Key laws and guidelines across East Africa, in brief
Browse short summaries of the main laws, regulations and guidelines that govern health products in each market. Every entry links to the official or published source.
Summaries are for orientation only and were last reviewed in November 2026. Regulations change, so always work from the current official text, or ask us to confirm the requirements for your product.
Country guides
The path to marketing authorization, country by country
Plain-language guides to how registration works in each market: who regulates, what you need before you apply, the typical steps, and what comes after approval.
How we work
A clear plan before any submission
- STEP 01
Assess
We review your product, existing documentation and target markets, and identify gaps against each authority's requirements.
- STEP 02
Plan
You receive a written regulatory strategy with the sequence of countries, required documents and realistic timelines.
- STEP 03
Prepare & submit
We compile and quality-check the dossier, submit it, and manage questions from the authority until a decision.
- STEP 04
Maintain
After approval we keep you compliant: renewals, variations, vigilance reporting and regulatory updates.
About us
Technical depth, regional reach, and integrity in every file
Gold Health Consulting PLC is a regulatory and quality consultancy based in Addis Ababa, Ethiopia. We help health product companies meet the requirements of East African regulators so that safe, quality products reach patients and consumers without avoidable delay.
Our consultants bring regulatory, quality and technical expertise across medicines, medical devices, cosmetics and food.
Integrity and independence
We prepare strong, honest submissions. We never promise guaranteed approvals or shortcuts around regulatory review.
Confidentiality
Your formulations, technical files and commercial plans are protected under signed confidentiality agreements.
Science-based quality
Our advice follows international references: ICH, WHO, IMDRF, ISO and Codex, applied to local requirements.
Regional perspective
One coordinated strategy across several East African markets, instead of separate efforts country by country.
Contact
Tell us about your product
Share a few details and we will reply within two working days with next steps and an initial view of the regulatory route.