A safe, high-quality pharmaceutical or health product can fail to reach patients due to misjudged regulatory pathways, incomplete technical dossiers, or unnavigated local registration requirements. In markets like Nigeria, products must navigate strict NAFDAC requirements for quality, safety, and efficacy, alongside separate trademark and standards registrations.
Product classification, regulatory pathway selection, and submission sequencing.
Gap analysis and quality oversight of Common Technical Document (CTD) Module 3 (CMC) files for clinical trial and marketing applications.
End-to-end registration support with NAFDAC, the Standards Organisation of Nigeria (SON), and the Trademark Registry.
Specialist registration pathways for consumer health products, cosmetics, food, and nutritional supplements in Nigeria.
Strategic advice on pharmacovigilance compliance, adverse event reporting, and market access through our specialist network.
Dossier evaluation workshops in CTD format for regulatory authority assessors and commercial regulatory affairs staff.
Capacity training for senior NAFDAC assessors on evaluating Module 3 (Quality) CTD dossiers.
Contributions to regional technical working groups producing harmonised CTD registration guidelines for West Africa.
Successfully registered consumer health, cosmetic, food, and beverage lines with NAFDAC, SON, and the Trademark Registry for manufacturers based in Taiwan, Turkey, Belgium, and Nigeria.
Led by Dr Chinedu Madichie (supported 5 clinical trial and IND filings), Mr Bolarinwa Yusuf (former Quality Manager, NAFDAC Drug Evaluation Directorate), and Mr Dele Aiyemowa (managing Nigerian product registrations with NAFDAC, SON, and Trademark Registry since 2006). Supported by a global regulatory network specialist who led regulatory teams across 48 countries with product approvals in 160+ markets.
