Comprehensive CRO Services

MDL Clintech Limited is positioning its specialized clinical and bioanalytical infrastructure to serve as an integrated solutions provider for early-phase clinical development, Bioavailability and Bioequivalence (BA/BE) evaluation, and regulatory biowaiver consultations. Our agile, collaborative framework and state-of-the-art facility in Nairobi, Kenya, give us the operational capacity to support generic pharmaceutical manufacturers, specialty innovators, and global health sponsors, accelerating your pathway from formulation optimization to commercial market authorization

In this integrated offering, our multidisciplinary technical teams deliver end-to-end support across the study lifecycle, ensuring rigorous compliance with ICH-GCP, GLP, and regional/international regulatory guidelines

Facility and Infrastructure

MDL Clintech’s dedicated clinical pharmacology and bioanalytical facility is purpose-built to deliver high-throughput, audit-ready data. Our infrastructure includes a modern BA-BE clinical pharmacology unit equipped with standardized confinement wards, continuous vital signs monitoring, regulated meal-preparation areas, and controlled-access drug storage

Our bioanalytical laboratories feature clean-classified sample preparation zones and advanced hyphenated analytical platforms (LCMS/MS,HPLC), backed by continuously monitored ultra-low temperature storage (-20℃ and -80℃) with backup power systems. Every operational area is validated under current GxP mandates to ensure complete separation of activities, strict chain-of-custody tracking, and full compliance with ALCOA+ data integrity standards

Core Services

Our specialized functional divisions provide integrated clinical, analytical, and regulatory solutions tailored to small molecule and biosimilar pharmacokinetic programs:

In Vivo BA/BE Study Execution

Fasting, fed, single-dose, multiple-dose, crossover, and parallel study designs in healthy volunteers

Bioanalytical Method Development & Validation

Rapid LC-MS/MS and HPLC method development, matrix validation, and high-throughput sample quantification compliant with ICH M10 guidelines

Incurred Sample Reanalysis (ISR)

Systematic ISR workflows to verify bioanalytical reproducibility across clinical study runs

BCS-Based Biowaiver Justification

Comprehensive documentation, permeability evaluations, and dossier authoring for BCS Class I and Class III molecules

In Vitro Comparative Dissolution Profiling 

Multi-media comparative dissolution testing with statistical factors calculations

Pharmacokinetic (PK) & Statistical Modeling 

Non-compartmental PK modelling, ANOVA statistical analysis, and 90% confidence interval calculations using validated software

Compliant Clinical Data Management 

Validated Electronic Data Capture (EDC) systems with computerized audit trails

Regulatory Affairs & CTD Compilation 

Authoring dossiers for submission to national health authorities (PPB, EAC regional harmonized blocks, and WHO Prequalification)

Expertise & The MDL Advantage

The scientific and operational leadership team at MDL Clintech brings extensive international expertise in clinical pharmacology, mass spectrometry, regulatory affairs, and quality assurance. We understand the critical importance of delivering on-time, audit-ready data to keep your commercialization timelines on track

Our leadership and operations are anchored in

Regulatory Precision

Deep alignment with ICH-GCP, WHO, US FDA, and EMA guidelines, alongside expertise in the East African Community Medicines Regulatory Harmonization pathway

Data Integrity & Compliance 

Uncompromising commitment to GxP compliance, independent Quality Assurance auditing, and secure electronic data management

Accelerated Timelines 

Streamlined volunteer recruitment workflows, automated cross checks to eliminate washout conflicts, and rapid bioanalytical sample processing

Transparent Project Governance 

Dedicated single point project management with real-time milestone tracking and proactive risk-mitigation protocols

 

The MDL Clintech advantage is built on three core pillars of client engagement is Accelerate, Comply, and Succeed providing dependable, science-led support to advance your pharmaceutical pipeline across African and global markets