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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BA/BE Studies
End-to-end clinical bioequivalence studies meeting global regulatory standards
Bioanalytical Science
LC-MS/MS and HPLC platforms with rigorous method validation under GLP principles
Regulatory Compliance
GCP/GLP/GCLP aligned PPB submission targeting USFDA, WHO, EMA acceptance
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
Bioanalytical Laboratory Services
Precision-driven quantitative analysis utilizing LC-MS/MS and HPLC on meticulously validated, globally esteemed platforms
Pharmacokinetics & Biostatistics
Non-compartmental pharmacokinetic evaluation, advanced statistical modeling utilizing ANOVA and mixed-effects approaches alongside TOST methodology for equivalence determination
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
Clinical Operations & Study Execution
Fasted and fed BA/BE studies under controlled, GCP compliant clinical environments, from volunteer recruitment through clinical monitoring
Clinical Operations & Study Execution
Fasted and fed BA/BE studies under controlled, GCP compliant clinical environments, from volunteer recruitment through clinical monitoring
Clinical Operations & Study Execution
Fasted and fed BA/BE studies under controlled, GCP compliant clinical environments, from volunteer recruitment through clinical monitoring
Our Core Principles
Quality-driven, compliance focused and committed to scientific and operational excellence
Quality Excellence
Robust QMS aligned with ICH, GxP and ALCOA+ principles at every operational level
Scientific Integrity
Accurate, reproducible, and audit-ready data that regulators and sponsors can trust
Ethical Research
Strict IRB/ethics adherence, informed consent and participant-centred study management
Regulatory Readiness
Infrastructure and systems engineered for
multi-authority inspection readiness from day one
Global Collaboration
Open, transparent partnerships with pharmaceutical
companies, biotech firms and research institutions worldwide
Continuous Imporovement
A culture of learning, benchmarking, and evolving best
practice drives every process we design
About MDL Clintech
A Purpose-Built BA/BE Contract Research Organization in Kenya
Founded in Nairobi, Kenya, MDL Clintech Limited has been 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 more than a Contract Research Organization. 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
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.
Why Partner with MDL Clintech?
From study design to final reporting, we combine scientific expertise, GxP-compliant processes and integrated capabilities to deliver reliable BA/BE research outcomes
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
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