// regulatory
Registration & compliance
Our products are registered or registerable in 40+ countries across Africa, MENA, and beyond. Our regulatory affairs team accompanies your import authorization process.
Export documentation
Every shipment is accompanied by the following documents. Available in FR, EN, AR on request.
📄 Certificate of Analysis (CoA)
Per batch, from manufacturer's QC lab
📄 Certificate of Pharmaceutical Product (CPP)
WHO-format, apostilled
📄 WHO-GMP certificate
Manufacturer's WHO-GMP compliance
📄 Halal certificate
Independently verified
📄 Bioequivalence study
vs originator brand
📄 Registration dossier (CTD format)
Modules 1-5 for import authorization
📄 SmPC
Summary of Product Characteristics
📄 Stability study
ICH Zone IVb (24-36 months)
📄 Free Sale Certificate
Issued by Moroccan Ministry of Health
📄 Halal + Kosher certificate
For MENA & Israeli market access
Country registration status
| Region | Countries | Status | Timeline |
|---|---|---|---|
| 🌍 West Africa (ECOWAS/UEMOA) | Senegal · Côte d'Ivoire · Mali · Burkina · Guinea · Benin · Togo · Cameroon · Niger | Registered / on-demand | 3-9 months |
| 🌍 Central Africa (CEMAC/OAPI) | Congo · Gabon · CAR · Chad · Equatorial Guinea | On-demand | 6-12 months |
| 🌍 East Africa | Kenya · Tanzania · Uganda · Rwanda · Ethiopia | Registered / on-demand | 4-10 months |
| 🌍 North Africa | Algeria · Tunisia · Libya · Mauritania · Egypt | Registered | 0 — active |
| 🕌 MENA | UAE · Saudi Arabia · Iraq · Yemen · Jordan | Registered / on-demand | 6-18 months |
| 🌏 South Asia | Pakistan · Bangladesh · Sri Lanka | On-demand | 9-18 months |
| 🌎 LATAM & Caribbean | Haiti · Dominican Rep. · Cuba | On-demand | 6-12 months |
Country not listed?
Our regulatory affairs team files new-country registrations in 3-6 months on average. Contact us to initiate the process.
Start country registration →