At MDL Clintech Limited, quality is not merely a control step, it is the governing principle embedded into every clinical, bioanalytical, and regulatory workflow. As Kenya’s pioneer GxP-compliant CRO, we operate under an uncompromising Quality Management System (QMS) designed to safeguard participant safety, guarantee strict adherence to global ethical guidelines, and deliver audit-ready data that withstands rigorous scrutiny by national and international health authorities

Global Regulatory Compliance & Alignment

ICH-GCP Compliance​ 

Complete adherence to ICH E6 guidelines across all trial phases, protocol designs, subject consenting, and clinical monitoring

ICH M10 Bioanalytical Standards

Full alignment with international harmonized standards for bioanalytical method development, validation, and sample quantification

Good Laboratory Practice (GLP) & GCLP

Rigorous laboratory standards governing bioanalytical execution, equipment qualification, and sample tracking

Regional & Continental Approvals

Direct alignment with Kenya’s Pharmacy and Poisons Board (PPB) regulations and the East African Community (EAC) Medicines Regulatory Harmonization guidelines

Global Agency Acceptance

Study frameworks structured to meet the scientific review standards of the US FDA, European Medicines Agency (EMA), and WHO Prequalification programs

Our Quality Management System (QMS)

Our comprehensive QMS provides end-to-end oversight across every facet of clinical trial execution and laboratory operations

Standard Operating Procedures (SOPs)

A robust matrix of validated, regularly reviewed SOPs governing all clinical, bioanalytical, data management, and QA activities

CAPA & Deviation Management 

A structured Corrective and Preventive Action (CAPA) framework ensuring root-cause analysis, risk mitigation, and continuous process optimization

Personnel Qualification & LMS 

Ongoing training programs managed through a validated Learning Management System, ensuring every investigator and analyst is qualified for assigned protocols

Change Control & Vendor Management

Rigorous evaluation processes for procedural changes, system updates, and third-party supplier qualifications

Independent Quality Assurance (QA) Unit

Operating completely independently from operational, clinical, and laboratory divisions, our Quality Assurance (QA) unit reports directly to executive management to maintain objective, uncompromised oversight across every study lifecycle

Our dedicated auditors enforce continuous vigilance across all operational touchpoints. In the clinic, QA conducts real-time in-process monitoring, dosing audits, and consent verifications to guarantee participant safety and strict protocol adherence. In our bioanalytical laboratories, the team oversees method validations, raw data integrity, and chromatography audit trails in full compliance with ICH M10 and GLP standards

To ensure regulatory acceptance, QA performs 100% audits of pharmacokinetic (PK) datasets, bioequivalence calculations, and final Clinical Study Reports (CSRs) to deliver defect-free, audit-ready dossiers. Backed by rigorous vendor qualifications and cold-chain supply audits, MDL Clintech guarantees complete data integrity and compliance from initial screening to final submission

Data Integrity Compliance 

Data integrity is the bedrock of regulatory acceptance at MDL Clintech Limited. We enforce strict ALCOA+ principles across every phase of data generation and management, ensuring that all clinical observations, bioanalytical injections, and record modifications are fully attributable to authorized personnel, captured contemporaneously in real time, and preserved in their original, accurate state without unauthorized post-acquisition changes

Our digital infrastructure is fully validated under Computerized Systems Validation protocols compliant with global regulatory stnadards. From Electronic Data Capture (EDC) in our clinical wards to Chromatography Data Systems (CDS) in our bioanalytical laboratories, all platforms feature secure user access controls and automated, unalterable audit trails, delivering transparent, tamper-proof, and audit-ready data for global health authorities

Inspection Readiness & Sponsor Audits

We maintain a permanent state of inspection readiness. MDL Clintech welcomes routine and study-specific audits by sponsor Quality Assurance teams, as well as formal regulatory inspections by national and international health authorities. Our dedicated audit support team ensures transparent documentation access, rapid query resolution, and seamless hosting for both on-site and remote audits