NAFDAC registration,
start to certificate.
We prepare the dossier, file it, answer the queries and see the product through to an approval you can trade on — for medicines, medical devices, food and supplements, and cosmetics.
01 The work
Most rejections are written before submission.
A NAFDAC submission fails far more often on internal inconsistency than on the science. A batch number that disagrees with the certificate of analysis, a shelf life stated two ways, a manufacturing address that doesn't match the GMP certificate — each one buys a query, and each query costs weeks.
So the bulk of our work is not filing. It is assembling the dossier and then cross-checking every claim against the signed source document it came from, before the agency does it for us.
What you get
- A gap review before you commit — what you hold against what is required
- CTD dossier assembled, formatted and internally cross-checked
- Submission through the agency portal, fees and formalities handled
- Query responses drafted, filed and followed up
- Inspection preparation where a facility visit applies
- The certificate, and the renewals and variations that follow it
02 Product categories
Medicines
Prescription and over-the-counter pharmaceutical products, including generics and novel dosage forms. Full CTD dossier, stability data, and manufacturing evidence.
Medical devices
Registration by risk class, with the technical documentation, conformity evidence and labelling review each class demands.
Food & food supplements
Processed foods, nutraceuticals and supplements — composition, labelling claims, shelf life and the analysis that supports them.
Cosmetics
Ingredient review against the permitted list, labelling compliance, and the safety documentation required for approval.
03 How it runs
Stage 01
Scope & gap review
What you hold against what is required, and an honest read on what is missing.
Stage 02
Dossier assembly
Modules built, formatted and cross-checked against the signed sources.
Stage 03
Submission
Filed through the agency portal with fees and formalities handled.
Stage 04
Queries
Answered, filed, and chased until they are closed.
Stage 05
Inspection readiness
Prepared for, where a facility or premises inspection applies.
Stage 06
Certificate & lifecycle
Approval, then renewals and variations to keep it current.
Tell us what you're bringing in.
Send us the product and where it's made. We'll come back with the route and what it needs.