Regulatory note: The NAFDAC requirements referred to in this guide come from NAFDAC's Guidelines for Registration of Imported Drug Products in Nigeria (DR&R-GDL-005-03, effective 20 March 2025), its renewal and reliance guidelines, and its Guidelines on Good Pharmacovigilance Practice (PV/PMS-GDL-017-01). Requirements should be confirmed against the current edition of each guideline.
Quick answer: A good regulatory consulting company in Nigeria works from NAFDAC's current guidelines, has qualified people on the ground in Nigeria, and can cover the whole product lifecycle. That starts with registration on NAPAMS, CTD dossiers, sample and GMP coordination, query responses, renewals, variations and pharmacovigilance, including a QPPV who resides and operates in Nigeria. It is transparent about fees and timelines, never guarantees an approval date, puts responsibilities in a written agreement, and tracks every NAFDAC deadline. Firms that promise shortcuts or fixed approval dates should be avoided.
What a Regulatory Consulting Company Does in Nigeria
Foreign manufacturers cannot register products with NAFDAC directly. Registration goes through a company incorporated in Nigeria, authorised by a Power of Attorney or a Contract Manufacturing Agreement. Many manufacturers use a regulatory consulting company to prepare, submit and manage that process, and to carry the obligations that follow approval.
Typical services include:
- Regulatory strategy, including which registration route applies to each product
- Document readiness: Power of Attorney, notarised declaration, COPP and GMP certificate authentication, trademark registration
- CTD dossier compilation and review
- Submission and tracking on NAFDAC's NAPAMS portal
- Coordination of sample import, laboratory analysis and GMP inspection
- Responses to NAFDAC queries within the deadlines
- Renewals, variations and advertising approvals
- Pharmacovigilance: QPPV services, the Pharmacovigilance System Master File, case reporting and periodic reports
Our guide on how to register a drug with NAFDAC explains each stage of the process a consultant would manage.
Why the Choice Matters
NAFDAC's processes leave little room for avoidable errors, and several of its rules punish delay directly:
- New registrations of imported drugs take 240 working days from acceptance, and the clock stops while a query is open
- Queries on new registrations must be answered within 90 working days, or the application closes automatically
- Renewals should start no later than 30 calendar days before expiry, and renewal queries must be answered within 45 working days
- Paying a fee does not confer registration, and filing an application is not approval
- Approval brings ongoing pharmacovigilance duties, including a QPPV resident in Nigeria and a master file held in Nigeria
A consultant who misses a query deadline or files an incomplete Power of Attorney can cost a manufacturer months. A consultant who handles registration well but leaves pharmacovigilance uncovered can leave a product compliant on paper and exposed in practice.
Ten Criteria for Choosing a Regulatory Consulting Company
1. Working Knowledge of Current NAFDAC Guidelines
NAFDAC updates its guidelines regularly. The imported drugs guideline in force today took effect in March 2025, and the reliance guideline in September 2024. A capable consultant can name the guideline that governs each step, cite its requirements, and explain what changed in recent editions. Answers built on old rules lead to queries.
2. Presence and People in Nigeria
NAFDAC's rules are built around a local presence: a Nigerian applicant incorporated with the Corporate Affairs Commission, a Superintendent Pharmacist licensed by the Pharmacists Council of Nigeria, premises with a valid retention licence, and a QPPV who resides and operates in Nigeria. A consultant without a real team in Nigeria cannot meet these requirements on its own.
3. Qualified Regulatory and Pharmacovigilance Staff
Dossier review, label assessment and safety case processing are technical work. The people doing it should have pharmacy, medical or life sciences qualifications and documented regulatory or pharmacovigilance experience. It is reasonable to ask who will work on the account and what their background is.
4. Coverage Across the Product Lifecycle
Registration is the beginning, not the end. The same products later need renewals, variations, advertising approvals and continuous pharmacovigilance. A consultant who covers both regulatory affairs and pharmacovigilance reduces handovers between providers and keeps the registration file and the master file consistent.
5. Dossier and CTD Capability
NAFDAC requires dossiers in Common Technical Document format for every risk category. The consultant should be able to compile and review Modules 1 to 5, check the Nigeria specific Module 1 content, and spot gaps before submission. Our NAFDAC registration documents checklist shows the scope of what has to be right.
6. Experience with Faster Routes
Products approved by a stringent regulatory authority, or prequalified by WHO, may qualify for NAFDAC's reliance or collaborative procedures, with a 60 working day decision target. A consultant should know when these routes apply and what they require, such as unredacted assessment reports and proof of product sameness. Our comparison of WHO prequalification and NAFDAC registration and our article on the African Medicines Agency cover these routes.
7. Query and Deadline Management
A missed query can close an application. The consultant should show how it monitors NAPAMS, how quickly it reports queries to the client, how it drafts responses, and how it tracks renewal dates and document expiries such as GMP certificates and Superintendent Pharmacist licences.
8. Transparency on Fees and Timelines
Professional fees should be separated from NAFDAC's official fees, which are set in the NAFDAC Tariff. Timelines should be explained against NAFDAC's published timelines, with the factors that can extend them. No consultant controls NAFDAC's decision, so no consultant can honestly guarantee an approval or an approval date.
9. Quality Systems and Confidentiality
Consultants handle unpublished dossiers, manufacturing data and safety information. Look for written procedures, document control, staff training records, confidentiality agreements and secure systems. For pharmacovigilance work, these quality arrangements will also appear in the client's own master file.
10. Communication and Track Record
Ask how often the consultant reports, through whom, and in what form. Ask for examples of similar products or therapeutic areas it has handled, and for references from existing clients where confidentiality allows.
Red Flags to Watch For
- A guaranteed approval, or an approval date shorter than NAFDAC's published timelines
- Offers to skip steps such as sample analysis or GMP confirmation
- Vague answers about who the QPPV is, or a QPPV who does not reside and operate in Nigeria
- No written agreement setting out responsibilities
- Official fees and professional fees blended into one unexplained figure
- Unfamiliarity with NAPAMS, the reliance procedure or current guideline numbers
- Suggestions to group several products into one application, which NAFDAC does not allow
- Reluctance to share copies of submissions and correspondence with the client
A Scorecard for Comparing Consultants
Use these criteria side by side when you assess more than one firm. Put the question in the final column to each consultant and compare the answers.
| Criterion | What good looks like | Question to ask |
|---|---|---|
| Guideline knowledge | Cites current NAFDAC guidelines and recent changes | Which guideline governs our product, and when did it take effect? |
| Local presence | Team, premises and QPPV in Nigeria | Where is your team based, and where does your QPPV live and work? |
| Lifecycle coverage | Registration, renewals, variations and pharmacovigilance | Who handles our safety reporting after approval? |
| Dossier capability | Compiles and reviews CTD Modules 1 to 5 | How do you review a dossier before submission? |
| Faster routes | Knows reliance and collaborative procedures | Does our product qualify for a reliance route? |
| Deadline control | Tracks queries, renewals and document expiries | How do you make sure no query passes its deadline? |
| Transparency | Separates official and professional fees | Which part of this quote is NAFDAC's fee? |
| Quality | Written procedures, training, confidentiality | Can we see your quality procedures? |
Setting Up the Engagement
Once a consultant is chosen, a clear written agreement protects both sides. It should set out:
- The scope of services, product by product
- Who acts as applicant and who holds the Certificate of Registration
- Who acts as QPPV, and how pharmacovigilance responsibilities are divided
- How documents, data and correspondence are shared and stored
- Reporting frequency and points of contact
- Fees, with official fees shown separately
- Confidentiality, data protection and what happens to files if the engagement ends
Under NAFDAC's pharmacovigilance guidelines, a company can delegate pharmacovigilance activities under written contracts, but it keeps full responsibility for its system, and those contracts must be listed in its Pharmacovigilance System Master File. Our comparison of in-house and outsourced QPPV models explains what oversight of a provider looks like.
The Wider Context: A Maturing Regulator
NAFDAC's standards keep rising. It holds WHO Maturity Level 3, which it has sustained through re-benchmarking, and it became a full member of the International Council for Harmonisation in November 2025. Registration has moved online to NAPAMS, covered in our guide to the NAFDAC online registration portal. These changes reward consultants who work to international standards and keep up with NAFDAC's guidance.
Consultant Selection Checklist
[ ] Works from current NAFDAC guidelines and can cite them
[ ] Team, premises and QPPV based in Nigeria
[ ] Qualified regulatory and pharmacovigilance staff named for the account
[ ] Covers registration, renewals, variations and pharmacovigilance
[ ] Compiles and reviews CTD dossiers
[ ] Assesses reliance and collaborative procedure eligibility
[ ] Shows a system for tracking queries, renewals and document expiries
[ ] Separates official and professional fees in writing
[ ] Has documented quality procedures and confidentiality arrangements
[ ] Agrees a written contract setting out all responsibilities
Frequently Asked Questions
Do I need a regulatory consultant to register a product with NAFDAC?
NAFDAC's guidelines require a Nigerian applicant rather than a consultant as such. A foreign manufacturer must register through a company incorporated in Nigeria, and many use a regulatory consulting company to prepare and manage the application and the obligations that follow.
What should a regulatory consulting company in Nigeria handle?
Registration strategy, document readiness, CTD dossiers, NAPAMS submissions, sample and GMP coordination, query responses, renewals, variations, advertising approvals and pharmacovigilance.
Can a consultant guarantee NAFDAC approval?
No. NAFDAC makes the decision, and its timelines stop while queries are open. A consultant can reduce delays but cannot guarantee an outcome or a date.
Should my regulatory consultant also provide pharmacovigilance?
It helps. Registration and pharmacovigilance are linked, since the master file is submitted with the registration application and the QPPV must reside and operate in Nigeria. One provider keeps the two consistent.
How long does NAFDAC registration take with a consultant?
NAFDAC's published timeline for imported drugs is 240 working days from acceptance, or 60 working days under reliance routes, with the clock stopped during queries. A consultant's role is to keep the file complete and queries answered on time.
How are consultant fees different from NAFDAC fees?
NAFDAC's official fees are set in its Tariff. Professional fees are what the consultant charges for its work. A clear quote shows them separately.
What red flags should I look for?
Guaranteed approvals, offers to skip steps, an unclear or non-resident QPPV, no written contract, blended fees and unfamiliarity with current guidelines or NAPAMS.
How MedNova Lifesciences Works
MedNova Lifesciences is a regulatory and pharmacovigilance partner for companies in Nigeria and across Africa. We provide regulatory affairs services covering NAFDAC registration, dossiers, NAPAMS submissions, renewals and variations, and pharmacovigilance services including local QPPV representation and master file management. We also support clinical development and offer training and consulting. See our capability statement.
Related reading: how to register a drug with NAFDAC, the complete guide to pharmacovigilance in Nigeria, our NAFDAC product registration guide, and the resources library.
Next step: contact our team to discuss your products and the right registration route.
References
1. National Agency for Food and Drug Administration and Control. Guidelines for Registration of Imported Drug Products in Nigeria, Human and Veterinary Drugs (DR&R-GDL-005-03).
2. National Agency for Food and Drug Administration and Control. Guidelines for Renewal of Certificate of Registration for Imported Drug Products in Nigeria (DR&R-GDL-025-01).
3. National Agency for Food and Drug Administration and Control. Guidelines for Registration and Related Activities of Drugs, Vaccines and In Vitro Diagnostics Using the Reliance Procedure (DR&R-GDL-035-00).
4. National Agency for Food and Drug Administration and Control. Guidelines on Good Pharmacovigilance Practice (PV/PMS-GDL-017-01), 2021.
5. National Agency for Food and Drug Administration and Control. NAFDAC announces a transition from observer status to full membership of the ICH.
6. National Agency for Food and Drug Administration and Control. NAFDAC's WHO ML3 re-benchmarking success.
7. National Agency for Food and Drug Administration and Control. Regulatory resources and guidelines index.
8. MedNova Lifesciences. Pharmacovigilance services, Nigeria and Africa.
9. MedNova Lifesciences. Regulatory affairs services, Nigeria and Africa