Obtaining Marketing Authorization (MA) quickly and efficiently is critical. Africa Lab Consulting is your strategic local partner, specializing in accelerating, securing, and optimizing your regulatory affairs in Africa. Medicines, medical devices and food supplements.
Decision-making support on priority markets in Sub-Saharan Africa, optimization of registration strategies, advice on product formats and local key success factors.
Preliminary assessment of the registrability of your products (medicines, medical devices, etc.) according to national and regional standards in Sub-Saharan Africa.
Rigorous compilation, local adaptation (translations, specificities), and official submission of CTD/eCTD dossiers. Meticulous follow-up until Marketing Authorization is granted.
Optimized submission planning, customized reporting (weekly/monthly), and active follow-up with authorities to ensure the rapid progress of your registrations.
Full management of MA renewals, variations (administrative, quality, clinical), line extensions for all product types (Rx, OTC, generics, cosmetics, medical devices, food supplements...).
Continuous monitoring of local MOH regulatory changes, proactive updates to your dossiers and support for implementing compliant pharmacovigilance systems.
Navigating the complex regulatory landscape of Sub-Saharan Africa requires specialized expertise and a local presence. Here’s how we make the difference:
We maintain direct and constant dialogue with African regulatory bodies, anticipating hurdles and resolving issues promptly for a smooth process.
Our in-depth knowledge of national and regional regulatory authorities and our local network allow us to significantly speed up the health product registration process.
Our experts master the specific requirements (e.g., CTD format, local requirements) of each Sub-Saharan African country, maximizing your chances of approval upon first submission of your MA dossier.
From initial feasibility analysis to post-marketing follow-up, we offer full-spectrum regulatory support built on transparency, efficiency, and measurable results. Our 360° approach ensures complete lifecycle management dossier preparation, submission, variations, renewals, and pharmacovigilance with real-time tracking, structured reporting, and direct communication with local authorities.
Don't let regulatory challenges hinder your expansion in Sub-Saharan Africa. Contact Africa Lab Consulting today for a personalized assessment of your project. Our tailored support will accelerate your market access and ensure product compliance. Our local expertise, strong network, and total commitment ensure efficient, fast, and transparent management of your registration and MA projects.
Custom regulatory and commercial strategies for success in Africa's healthcare markets.
