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Supporting Global Bioavailability Bioequivalence Research from Nairobi, Kenya

MDL Clintech Limited is building East Africa's most advanced GxP compliant Bioavailability/Bioequivalence facility purpose-built to serve global pharmaceutical development programs

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Why MDL ClinTech

Two Decades of Experience, Engineered Into Every Study

MDL Clintech Limited carries decades of combined global CRO expertise into a purpose-built Nairobi facility where scientific rigor, regulatory precision, and operational discipline come together for every sponsor we serve.

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"Two decades of experience. One clear mission bringing world-class bioequivalence science to Africa."

Our Core Principles

Quality-driven, compliance-focused, and committed to scientific and operational excellence across every stage of our work.

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Quality Excellence

Robust QMS aligned with ICH, GxP, and ALCOA+ principles at every operational level.

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Scientific Integrity

Accurate, reproducible, and audit-ready data that regulators and sponsors can trust.

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Ethical Research

Strict IRB and ethics adherence, informed consent, and participant-centred study management.

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Global Collaboration

Open, transparent partnerships with pharmaceutical companies, biotech firms, and research institutions worldwide.

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Continuous Improvement

A culture of learning, benchmarking, and evolving best practice drives every process we design.

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Regulatory Readiness

Infrastructure and systems engineered for multi-authority inspection readiness from day one.

Advancing affordable healthcare by delivering world-class bioequivalence and bioavailability studies across Africa.

Providing rigorous clinical data and bioanalytical precision to accelerate generic drug approvals locally and globally.

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How can we conduct fast, cost-effective bioequivalence trials compliant with global regulatory standards?
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Where can we access a diverse, treatment-naive healthy volunteer pool for pharmacokinetic studies in East Africa?
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What is the fastest regulatory pathway for product registration across the East African Community?

About MDL Clintech

A Purpose-Built BA/BE Clinical Research Organization in Kenya.

MDL Clintech Limited is established with a singular vision which is to create a world-class clinical research infrastructure that meets and exceeds the expectations of international regulatory authorities, pharmaceutical innovators and patients worldwide. 


We are a scientific partner committed to accelerating the development of safe, effective and affordable medicines by generating the highest-quality clinical pharmacology data from one of Africa's most dynamic research environments.


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Services we Provide

MDL Clintech Limited offers a range of integrated clinical research support services focused on quality, compliance and operational excellence in Bioavailability/Bioequivalence (BA/BE) studies

Clinical Operations & Study Execution

Performed fasted and fed bioavailability/bioequivalence studies in controlled, GCP-compliant clinical environments, handling all aspects from volunteer recruitment to clinical monitoring 

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BA/BE Studies

Comprehensive clinical bioequivalence studies conducted from start to finish, ensuring compliance with international regulatory requirements and standards

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Bioanalytical Laboratory Services

Precision-driven quantitative analysis utilizing LC-MS/MS and HPLC on meticulously validated, globally esteemed platforms

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Pharmacokinetics & Biostatistics

Non-compartmental pharmacokinetic evaluation, advanced statistical modeling utilizing ANOVA and mixed-effects approaches alongside TOST methodology for equivalence determination 

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Regulatory Documentation & Reporting

Clinical trial protocols, informed consent agreements, comprehensive clinical study reports and meticulously prepared submission dossiers adhering to ICH standards and international regulatory expectations 

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Why MDL Clintech Matters?

Although East Africa boasts a rich genetic diversity, a highly skilled scientific workforce, and rapidly advancing regulatory frameworks, it has remained an underrepresented region in global clinical research. MDL Clintech was established to transform this landscape. 

Global Regulatory Alignment

Our systems, documentation, and processes are designed from the ground up to meet USFDA, WHO, EMA, MHRA, ANVISA and PPB standards

Pioneer CRO in East Africa

Among the first organizations in Kenya to establish a purpose-built, GxP-compliant BA/BE clinical research facility

Scientific Leadership

Our multidisciplinary team brings expertise spanning clinical pharmacology, bioanalytical science, quality assurance, regulatory affairs and data management

What support do we offer?

We provide 24/7 support through various channels, including live chat, email and phone, to assist with any queries.

Ready to Partner?

Our scientific and project management teams are available to discuss your study requirements, provide detailed capability presentations, and develop a tailored proposal that meets your regulatory and timeline objectives. We look forward to becoming your trusted BA/BE research partner in East Africa

Integrated Expertise

Single-source BA/BE partner - clinical, bioanalytical, PK/statistics and regulatory writing under one roof

Quality & Compliance

GxP-compliant operations from protocol design through final CSR delivery

Advanced BA/BE Capabilities

Access to East Africa's most scientifically advanced and regulatory-ready BA/BE facility


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