We guide pharmaceutical products through every stage of the regulatory lifecycle across African markets — from initial registration strategy to post-approval maintenance and renewals. Our regulatory specialists combine local knowledge with international best practice to ensure your market access is fast, compliant, and sustainable.
We align with global regulatory frameworks including ICH and WHO guidelines while maintaining a deep, current understanding of NAFDAC and the regulatory environments across African jurisdictions.
What our regulatory affairs services deliver
From first-time NAFDAC registration to managing a mature multi-country portfolio, our team handles the regulatory complexity so you can focus on your business.
Core capabilities include:
- Regulatory strategy, pathway assessment, and feasibility studies
- Product registration with NAFDAC and other African authorities
- CTD and eCTD dossier preparation and review
- Post-approval variations (Type IA, IB, II), renewals, and labelling changes
- Trademark registration and brand name approval
- GMP inspection readiness and manufacturing site audit support
Our regulatory affairs capabilities
Our regulatory affairs team delivers end-to-end services across every phase of the product lifecycle — from strategy through registration, maintenance, and renewal.
Regulatory Strategy & Intelligence
Market entry strategy and regulatory pathway assessment, regulatory gap analysis and feasibility studies, continuous monitoring of guideline changes across African jurisdictions, and multi-country submission planning.
Product Registration
New product registration with NAFDAC and other African regulatory authorities across all categories — prescription, OTC, herbal, and biologics. Includes dossier preparation in CTD and eCTD formats, import permits, free sale certificates, regulatory liaison, query response management, and registration renewals.
Post-Approval Regulatory Maintenance
Post-approval variations (Type IA, IB, II), labelling and artwork review, pack size changes and reformulations, manufacturing site changes and GMP updates, and sunset clause management — ensuring your registrations remain valid and current.
Trademark & Intellectual Property
Trademark registration and renewal, brand name screening and regulatory name approval, and IP strategy support for pharmaceutical products across African markets.
GMP & Inspection Support
GMP inspection readiness and mock inspections, manufacturing site audit support, and GMP documentation review — ensuring your facilities are always inspection-ready and your dossiers reflect current manufacturing reality.
How we manage your regulatory lifecycle
We begin with your products, target markets, and current regulatory position — then build a submission strategy that maximises speed to approval while minimising risk.
Regulatory Assessment & Strategy
We assess your product, target markets, and current dossier status — then design a regulatory pathway and multi-country submission plan aligned with your commercial timelines.
Dossier Preparation & Submission
We prepare your CTD or eCTD dossier, manage all regulatory liaison and query responses, and handle the submission process with NAFDAC and other African authorities.
Post-Approval Maintenance & Portfolio Management
We manage all post-approval variations, renewals, labelling changes, and regulatory intelligence — so your registrations remain valid and your portfolio stays fully compliant.