The Challenge: "No Local Presence, No Problem?"
Our client, a mid-sized Indian generic manufacturer, aimed to expand its footprint into the West African region, with Nigeria as the primary entry point. They identified a portfolio of 5 essential generic medicines ready for registration.
However, they faced a classic "Catch-22":
No Local Office: NAFDAC regulations strongly favor (and in practice, require) robust local representation for communication and product listing.
Unfamiliar Dossier Requirements: While the company had strong technical files, they were compiled according to ICH guidelines, not the specific "CTD" nuances and administrative requirements demanded by NAFDAC (such as specific Certificate of Pharmaceutical Product (CPP) nuances, specific GMP documentation, and local agent affidavits).
Aggressive Timeline: The client had already committed to a distributor in Lagos that product revenue would begin flowing within 6 months. Failure to register on time meant contractual penalties and lost shelf space.
