About Regnova

Building Ghana’s trusted medical device gateway

Regnova was founded to bridge the gap between global innovators and Ghana’s regulatory landscape. Our Accra-based regulatory, clinical, and logistics specialists guide manufacturers from dossier strategy to in-market performance so lifesaving technologies reach patients compliantly.

Regnova team collaborating on regulatory strategy

Our Story

Founded with a mission to enhance healthcare innovation in Ghana, RegNova bridges the gap between emerging health technologies and regulatory compliance.

As a trusted local representative licensed by the Ghana FDA, we serve as a launchpad for global medical device companies seeking to enter and thrive in the Ghanaian market. We combine on-the-ground expertise with regulatory precision to help our partners move from approval to distribution with speed, efficiency, and compliance.

We are committed to helping companies navigate the complex landscape of the Ghana FDA regulatory environment — so that innovation reaches those who need it most.

Our Mission

To empower healthtech companies to achieve regulatory approval and transform healthcare delivery across Ghana and beyond.

Our Vision

A future where innovative medical technologies reach the people of Ghana without regulatory barriers — accelerating access to life-saving care and advancing public health outcomes.

Click here to learn more about our services and how to partner with us.Explore services

Capabilities

Integrated services tailored for African market entry

Regnova combines regulatory strategy, clinical governance, and operational enablement so manufacturers maintain compliance from dossier submission through nationwide scale-up.

Regulatory excellence

Our regulatory affairs team has managed hundreds of Ghana FDA submissions, mapping global evidence to local requirements, mitigating gaps early, and maintaining transparent authority relationships throughout review.

Clinical collaboration

Regnova clinicians and biomedical engineers co-design onboarding, training, and post-market monitoring programs with hospital partners to ensure safe adoption and measurable patient impact.

Distribution infrastructure

From customs clearance and cold-chain warehousing to last-mile delivery, our logistics network keeps devices compliant and available across Ghana’s public and private health facilities.

Post-market intelligence

Our PMS portal captures complaints, adverse events, and field data in real time—feeding insights back into regulatory reporting, quality management, and partner decision-making.

Leadership & advisory team

Regnova’s leadership team blends regulatory specialists, biomedical engineers, and local market operators who have guided approvals across cardiology, diagnostics, surgical, and digital health portfolios since 2018.

Our advisory board includes Ghanaian clinicians and global QA/RA experts who oversee compliance strategy, health economics, and clinical adoption programs for partner manufacturers.

Team member 1

Fotoğraf placeholder: 600×600px görsel. Biyografi metni eklenecek.

Team member 2

Fotoğraf placeholder: 600×600px görsel. Biyografi metni eklenecek.

Team member 3

Fotoğraf placeholder: 600×600px görsel. Biyografi metni eklenecek.

Team member 4

Fotoğraf placeholder: 600×600px görsel. Biyografi metni eklenecek.

Work with us

Ready to explore a partnership?

Collaborate with our regulatory and clinical teams to accelerate your Ghana FDA submissions, scale distribution, and maintain compliant post-market operations.

Partner with us