Services
From navigating approvals to streamlining distribution and ensuring compliance, RegNova is your trusted local partner every step of the way.
📋 01. Regulatory Strategy
We guide your company through the Ghana FDA regulatory landscape with customized strategies based on your device class, risk profile, and global approvals.
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🗂 02. Product Registration
We manage the full lifecycle of your Ghana FDA application — saving you time, reducing rejections, and fast-tracking your market entry.
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🏥 03. Importation & Distribution
We offer full-service logistics and last-mile distribution to ensure your devices reach the right facilities — safely and legally.
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🔄 04. Post-Market Surveillance (PMS)
We handle everything from complaint tracking to adverse event reporting and recall coordination to ensure compliance after market launch.
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🧾 05. SOP Development & Quality Consulting
We help you craft or refine Standard Operating Procedures tailored to Ghana’s regulatory standards.
Services include
30–45 minute call to scope your device, indications, and timelines. We perform a quick gap analysis and confirm required evidence and labeling needs.
We compile the dossier, file with Ghana FDA, and manage authority queries end-to-end. You get a clear tracker and single point of contact.
We coordinate import/customs, training, and go-live. Your PMS dashboard tracks complaints, AEs, CAPA, and recall readiness.
Contact us to speak with our regulatory team and explore tailored solutions for your business.
Contact our team