Nigerian export and Regulatory specialist with 5 years of experience guiding pharmaceutical companies through NAFDAC registration, FDA compliance and West African Market entry.
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Bachelor of Pharmacy, University of Jos Plateau State, Nigeria
licensed with Pharmacy council of Nigeria
Microbiology in University of Calabar, Cross River State Nigeria
NAFDAC product registration,
Import permits,
Label compliance Review
Liason with PCN
Due diligence audits
Export Documentation
Strategic Reclassification & Dossier Overhaul
Step 1: Regulatory Intelligence
We first clarified the exact regulatory "class" for each of the 10 products. We identified that 7 could go through a streamlined "Food" registration, but 3 would require the full "Drug" registration pathway due to their high dosage.
Step 2: Gap Analysis & Testing Coordination
We advised the client to conduct the specific heavy metals and microbial tests required by NAFDAC at an Indian NABL-accredited lab. We then mapped these results directly to the NAFDAC application forms.
Step 3: Labeling Remediation
We provided a "red-line" markup of the proposed packaging, instructing the client on the mandatory removal of specific medical claims (e.g., "cures deficiency") and the addition of the mandatory "Not for medicinal use" or specific warning statements required locally.
We provided a comprehensive "end-to-end" Regulatory representation and dossier remediation service.
Phase 1: Gap Analysis & Dossier Remediation (Month 1)
We conducted a full audit of the 5 dossiers against the current NAFDAC "Green Book" requirements.
Identified Gaps: We discovered that 3 of the 5 dossiers lacked the specific "Manufacturer's License" that needed notarization specifically for Nigeria, and 2 products required additional stability data submitted in a specific format not previously provided.
Remediation: We worked with the client's R&D team in India to reformat the stability summaries and secured the correctly notarized copies of the licenses.
Phase 2: Establishing Legal Presence (Month 2)
Since the client had no office in Nigeria, we facilitated the engagement of a licensed NAFDAC local agent and ensured all Letters of Authorization (LoA) were drafted correctly to avoid rejection at the "due diligence" stage.
Phase 3: Submission & Follow-Up (Months 3-5)
We managed the electronic submissions via the NAFDAC portal and provided ongoing status updates. We also managed the "post-approval" documentation required for the issuance of the final Listing Numbers.
