Quality Management

The ICH guidelines on Good Clinical Practice (GCP) E6 (R3), particularly Section 3.11, require the establishment of quality assurance (QA) and quality control (QC) procedures for clinical trials.

It is the sponsor's duty to develop and uphold QA and QC processes, which should be governed by documented procedures. These systems are designed to ensure that clinical trials are conducted, data are generated, recorded and reported in accordance with the protocol, GCP, and applicable regulatory requirements. The quality management system should incorporate a risk-based approach to enhance the efficiency and effectiveness of these processes.

The Quality Management division extends its expertise, developed through the maintenance and continuous improvement of our ISO-certified Quality Management System (QMS), to support external clients.

We support clinical study sponsors in designing and implementing Quality Management Systems (QMS) focused exclusively on quality processes—not clinical trial execution. Our services include gap assessments, QMS framework development, SOP creation, and implementation guidance, in line with ISO 9001 standards. The resulting system enhances compliance, ensures audit and inspection readiness and enables continuous improvement in quality oversight.

Our Services

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Quality Gap Assessment Identify gaps in existing quality processes and evaluate alignment with ISO 9001 and regulatory expectations.
QMS Design and Documentation Develop a tailored quality framework, including quality policies, SOPs, and supporting documentation.
Implementation Support
 Provide guidance and practical support for rollout, staff training, and readiness for audits or inspections.