Accredited, Audited & Regulatory Compliant

Dr. Dangs Lab's commitment to excellence in clinical diagnostics and central laboratory services is evident through our rigorous quality standards and regulatory compliance.

Dr. Dangs Lab Central Lab 40 years of diagnostic excellence badge

Dr. Dangs Lab Quality Policy

Dr. Dangs Lab LLP is committed to delivering accurate, reliable, and timely testing services as both a diagnostic laboratory and a central lab supporting clinical trials and clinical studies. All services are provided within a professional, ethical, and reassuring environment, with a consistent focus on quality, safety, and regulatory compliance.

The laboratory supports patients, clinicians, and clinical trial partners across Clinical Biochemistry, Hematology, Clinical Pathology, Cytopathology, Microbiology and Infectious Disease Serology, and Molecular Testing. In its role as a central reference laboratory, Dr. Dangs Lab is dedicated to meeting the quality expectations of regulated clinical research while maintaining high standards of routine diagnostic practice.

Dr. Dangs Lab operates in compliance with ISO 15189:2022, GCLP-certified and operates under relevant guidelines issued by the NABL. These standards are implemented uniformly across all laboratory locations to ensure consistency, reliability, and data integrity.

The Quality Management System is designed to ensure satisfaction of patients, clinicians, and research partners through personalized services, while upholding the principles of objectivity, integrity, confidentiality, and impartiality. The system emphasizes patient and staff safety and focuses on continual improvement through adoption of appropriate technologies, adherence to good professional practices, periodic equipment upgrades, methodological enhancements, employment of competent personnel, regular training programs, and internal audits.

Dr. Dangs Lab commits to the effective implementation and ongoing maintenance of this Quality Policy across all locations through the active participation and accountability of its laboratory personnel.

Components of the Quality Management System

As a central lab, Dr. Dangs Lab maintains a structured Quality Management System encompassing the following core components:

Quality Audits

Quality oversight at Dr. Dangs Lab is governed by a structured audit framework designed to support regulatory compliance, data integrity, and continuous improvement across the clinical trial lifecycle. These processes reflect the level of rigor expected of a laboratory operating as a central lab within regulated clinical research.

Internal Audits

Internal audits are performed by in-house Quality Assurance personnel trained in GCLP and ISO 15189:2022 requirements. Audit activities are planned and executed at predefined stages of each study to verify adherence to approved protocols, standard operating procedures, and applicable regulatory guidelines.

Pre-initiation
Initiation
In-process
Study Data Audits
End of Study
Study Closure

External Audits

In addition to internal oversight, Dr. Dangs Lab routinely supports external audits conducted by independent bodies and research partners. Our central laboratory has undergone more than 40 national and international audits as part of its role in clinical trials and clinical studies. These external evaluations reinforce our readiness to meet sponsor expectations and regulatory scrutiny associated with central lab operations.

NABL & External Regulatory AuditsVendor - Sponsor AuditsVendor - CRO Audits