Scientific Excellence

Our multidisciplinary team combines clinical, scientific, and regulatory experience.

Patient Safety

Specialized services in Pharmacovigilance and Drug Safety to ensure compliance.

Strategic Approach

Tailored solutions for regulatory affairs, quality systems, and market success.

Innovative Solutions

Advancing health systems through science, integrity, and continuous support.

Who We Are

Dr. Mwiko Health Solutions Ltd is a Kenya-based consulting company with global operations providing specialized services in:

  • Pharmacovigilance (PV) and Drug Safety
  • Regulatory Affairs (RA) and CMC Support
  • Medical Information Services
  • Good Distribution Practices (GDP) and Quality Systems
  • Training and Capacity Building
  • Clinical Research Support and Safety Oversight
  • Company As A Service (CaaS)

Our multidisciplinary team combines clinical, scientific, and regulatory experience to deliver end-to-end solutions that enhance product safety, compliance, and market success.​ With operations spanning the whole of Africa and Globally, we are positioned as a trusted partner for both global and regional health organizations.

Who We Are

Our Services

Comprehensive Health
Solutions For You

Pharmacovigilance

End-to-end pharmacovigilance services for Africa, including QPPV, audits, signal management, ICSR processing, and PSMF support. Ensure patient safety and regulatory compliance.

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Regulatory Affairs

Complete Regulatory Affairs and CMC services for Africa. We manage submissions, clinical trial applications, and labeling to ensure faster approvals and long-term market success.

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Medical Information Services

End-to-end Medical Information support, including enquiry management, database setup, and safety triage. Deliver accurate, compliant responses to HCPs and patients.

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LTR Services

Your trusted Local Technical Representative (LTR) in Kenya. We handle PPB liaison, dossier submissions, and compliance to maintain your product's market presence.

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GDP Compliance and Support

Full GDP compliance support for the pharmaceutical supply chain in Africa. We provide audits, licensing support, and temperature control mapping to safeguard product integrity.

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Training

Empower your team with expert-led training in Regulatory Affairs, Pharmacovigilance, and GDP. Build competence and compliance with global standards tailored for Africa.

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Company as a Service

Our integrated Company as a Service (CaaS) model provides Regulatory, PV, Quality, and Sales Force management under one partnership for efficient market operations across Africa.

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Why Dr. Mwiko?

Why Dr. Mwiko?

At Dr. Mwiko Health Solutions Ltd, we believe that scientific excellence and ethical leadership are the cornerstones of better health outcomes.​

Our approach blends technical expertise, regulatory insight, and regional experience to help organizations meet the highest standards in Pharmacovigilance, Regulatory Affairs, Quality, and Training across Africa and beyond.

We build partnerships rooted in integrity, precision, and progress. Whether it’s establishing compliant systems, managing product safety, or strengthening institutional capacity, we provide tailored, scalable solutions that empower companies and regulators to make confident, data-driven decisions.

Latest Insights

Expert insights, regulatory updates, and thought leadership on the future of pharmacovigilance, regulatory science, and health systems strengthening in Africa.

Understanding Pharmacovigilance: A Guide for Healthcare Providers

By Admin • Nov 08, 2025

Understanding Pharmacovigilance: A Guide for Healthcare Providers
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The Importance of Accurate Medical Information Services

By Admin • Nov 08, 2025

The Importance of Accurate Medical Information Services
Read More →
How Regulatory Affairs Ensure Medicine Safety in Kenya

By Admin • Nov 08, 2025

How Regulatory Affairs Ensure Medicine Safety in Kenya
Read More →
Dr Mwiko Health Solutions Ltd

Dr Mwiko Health Solutions Ltd
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