From Uncertainty to Full Compliance
Navigating Nigeria's healthcare regulatory landscape can be complex and time-consuming. Our team of compliance specialists provides clear guidance across every requirement — from initial registration to ongoing audits and renewals.
- Licensing & registration support for medical devices, pharmaceuticals, and healthcare facilities.
- Quality Management System (QMS) implementation aligned with ISO 13485, ISO 9001, and WHO standards.
- Pre-audit preparation & mock inspections for JCI, SON, NAFDAC, and state health ministries.
- Continuous monitoring & alerts on regulatory changes affecting your operations.
What Our Regulatory Advisory Covers
Tailored solutions for medical device importers, hospitals, manufacturers, and health programs.
Licensing & Permits
End-to-end support for NAFDAC product registration, SON CAP certification, Wholesale/Retail Pharmacy licenses, and facility permits from state health ministries.
Quality Management Systems
Design, documentation, and implementation of ISO 13485:2016 (medical devices) and ISO 9001:2015 QMS. Includes internal audit training and certification support.
Audit & Inspection Readiness
Pre-audit gap assessments, mock inspections, and corrective action plans. We prepare your team for NAFDAC, SON, JCI, WHO, and donor agency audits.
Medical Device Registration
Full support for NAFDAC Medical Device Establishment registration, product listing, and renewal — including dossier preparation, testing coordination, and liaison.
Regulatory Strategy & Roadmap
For new market entrants or expanding product lines — we develop a multi-year regulatory roadmap, timelines, and budget for domestic and export approvals.
Technical Documentation
Preparation of technical files, risk management reports (ISO 14971), clinical evaluation reports, and post-market surveillance plans for regulatory submissions.
We Guide You Through Every Requirement
NAFDAC
Product registration, establishment licensing, GMP inspection, and post-market surveillance for medical devices and pharmaceuticals.
SON (CAP)
Mandatory Conformity Assessment Program for imported medical devices. We manage the entire SONCAP certification process.
ISO 13485
Quality management for medical devices — from QMS documentation to certification body liaison.
JCI / WHO
International accreditation readiness for hospitals, labs, and blood banks — including pre-assessment and staff training.
Regulatory Expertise You Can Trust
Deep Local & International Knowledge
Our team includes former regulators, certified auditors, and quality experts with decades of combined experience across Nigeria, EU, and US regulatory systems.
Direct Agency Liaison
We maintain direct working relationships with NAFDAC, SON, PCN, and state health inspectorates — enabling faster resolutions and transparent tracking.
Post-Approval Support
We don't disappear after approval. Our annual retainer packages include license renewals, regulatory updates, and ongoing audit support.
"GBioMed guided us through NAFDAC registration for 15+ medical devices in under 8 months — something we previously struggled with for over two years. Their regulatory roadmap saved us months of trial and error."
— Compliance Director, International Medical Distributor