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Health Regulatory & Compliance


Navigating complexity. Ensuring readiness. Protecting patients.

Disclaimer: Regulatory compliance advice is highly fact-specific. This page describes our service offerings but does not constitute legal advice or guarantee any particular outcome.
We don't just help you comply. We help you stay open, avoid shutdowns, and scale safely. Regulatory failure in Nigeria is not theoretical – it closes businesses.

Overview

Healthcare is among the most regulated sectors in any economy. In Nigeria, the regulatory architecture spans NAFDAC, PCN, MDCN, NMCN, HEFAMAA, NHIS, and state ministries – each with its own rules, inspectors, and enforcement appetite.

For hospitals, community pharmacies, diagnostic laboratories, pharmaceutical companies, and health tech platforms, a delayed license means a closed facility. A failed inspection means a seized product. A compliance gap means enforcement that can destroy years of reputation.

Services

NAFDAC Registration & Renewal

Full lifecycle management.

Community Pharmacy Compliance

PCN premises registration, controlled substances recordkeeping, wholesale/retail licensing, supervising pharmacist obligations, inspection readiness.

Diagnostic Laboratory Accreditation

HEFAMAA/state licensing, MLSCN requirements, biosafety, waste management, quality assurance, radiology safety.

Healthcare Facility Licensing (Hospitals & Clinics)

HEFAMAA registration, state processes, tertiary hospital governance.

Professional Practice Compliance

Scope-of-practice rules, CPD documentation, telemedicine standards.

Pharmacovigilance & Adverse Event Reporting

Drug safety systems, periodic safety update reports.

NAFDAC GMP Inspections & Supply Chain Integrity

Good Manufacturing Practice audits, track-and-trace serialisation, pharmaceutical distribution compliance.

Regulatory Due Diligence for Investments

M&A, private equity, venture capital for pharmacy chains and diagnostic lab networks.

Policy Engagement & Legislative Advocacy

Position papers, regulator engagement, committee representation.

Compliance Training & Governance Frameworks

SOPs, training, mock inspections for pharmacies, labs, hospitals.

Why The Sanu Attorneys for Regulatory & Compliance?

  • We understand the day-to-day realities of community pharmacies and diagnostic labs – not just hospitals.
  • Our digital health expertise means we also address e-pharmacy and tele-lab compliance.
  • We have engaged regulators directly – helping shape, not just follow, the rules.

Schedule a Confidential Consultation

Schedule a Confidential Consultation